Injection device

ABSTRACT

Apparatuses and methods for delivering a fluid, including a viscous fluid. These apparatuses may include a fluid reservoir, two or more piston chambers, a manifold, a delivery port, and a drive assembly and may be configured to inject either a predetermined amount of fluid or a continuous stream of fluid. These apparatuses may also be configured to switch between filling, injection and aspiration modes. These apparatuses may generally be hand-held and lightweight and may provide a significant mechanical advantage to the user.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of U.S. patent applicationSer. No. 17/223,976, filed Apr. 6, 2021, titled “INJECTION DEVICE,” nowU.S. Pat. No. 11,229,750, which claims priority to U.S. ProvisionalPatent Application No. 63/006,056 filed Apr. 6, 2020, and titled“AUTOMATIC FLUID EXPULSION DEVICE,” each of which are hereinincorporated by reference in their entirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

This disclosure is generally related to apparatuses and methods fordelivering a fluid to a patient. More specifically, this disclosurerelates to delivering a viscous fluid, such as a pharmaceutical drug oran injectable material, to a patient.

BACKGROUND

Every year, more than 600,000 knee replacements and more than 300,000hip replacements are performed in the United States alone. Some 2.6million people get facial cosmetic surgery. Pain medications forreplacements and fillers for cosmetic surgery are delivered intomultiple locations on a knee, hip or face, requiring a relatively largenumber of injections of significant volumes. Tissues in the knee, hip,and face, such as muscle, ligaments, and tendons, and other connectivetissue are dense and fibrous and resist injection, at least in partbecause pain medications for replacements and fillers for cosmeticsurgery are viscous. Viscous fluid typically does not flow well. Viscousfluids can be difficult to expel from a syringe (the current method fordelivering these fluids. Expelling a viscous fluid or injecting aresistant tissue requires higher pressure; thus viscous solutionsgenerally take more time to inject, and injecting large quantities ofpain medications and fillers can be time-consuming. Expelling a viscousfluid from a syringe can be hard on the operator's hands, and inparticular, expelling a large quantity of fluid from a syringe can behard on the operator's hands. This difficulty may be compounded wheninjecting a fluid into resistant tissues.

Current methods of delivering viscous fluids using hand-held syringessuffers from these and other many drawbacks. Described herein areapparatuses and methods to deliver viscous fluids in a manner that mayaddress these drawbacks and delivers pain medications, fillers, andother viscous fluids in a manner that is easy, safe, and fast for thebenefit of both the patient and the operator providing the treatment.

SUMMARY OF THE DISCLOSURE

Described herein are methods and apparatuses (e.g., devices, systems,assemblies, etc.) for injecting fluid, and particularly viscus fluid,into a tissue. These apparatuses may be hand-held apparatuses that candeliver multiple doses of pre-set (e.g., selectable) volumes and/orpressures and/or flow rates of viscus material into the tissue.

For example, described herein are apparatuses for automatic expulsion ofa fluid having a body configured to be held in a user's hand, the bodycomprising: a storage chamber; a first delivery chamber fluidicallyconnected to the storage chamber through a first port; a second deliverychamber fluidically connected to the storage chamber through a secondport; a delivery port fluidically connected to the first deliverychamber and the second delivery chamber; and a drive system comprising atransmission operatively connected to the first delivery chamber and thesecond delivery chamber, wherein the drive system is configured toprovide a continuous expulsion of fluid from the delivery port byalternately expelling fluid from the first delivery chamber out of thedelivery port while filing the second delivery chamber with fluid fromthe storage chamber and ejecting fluid from the second delivery chamberout of the delivery port while filling the first delivery chamber withfluid from the storage chamber.

Any of these devices for automatic expulsion of a fluid may include: ahand-held housing configured to hold a storage chamber, a first deliverychamber, and a second delivery chamber, a fluid transfer manifold, and adrive system; a fluid transfer manifold in the housing, the fluidtransfer manifold configured to fluidically connect the storage chamberto the first delivery chamber through a first fluidic pathway, toconnect the storage chamber to the second delivery chamber through asecond fluidic pathway, and to connect the first delivery chamber andthe second delivery chamber to an output port; and a drive system in thehousing, the drive system comprising a transmission configured tooperatively connect to the first delivery chamber and to the seconddelivery chamber, wherein the drive system is configured to provide acontinuous expulsion of fluid from the output port by alternatelyexpelling fluid from the first delivery chamber out of the delivery portat 100 psi or more while filling the second delivery chamber from thestorage chamber, and expelling fluid from the second delivery chamberout of the delivery port at 100 psi or more while filling the firstdelivery chamber from the storage chamber.

The drive system may further comprise a motor configured to drive thetransmission and a power source configured to power the motor. In someexamples the drive system comprises a battery or a mechanical driverconfigured to drive the transmission. The transmission may comprise atiming belt. The drive system may be configured to turn the timing beltalternately clockwise and counterclockwise.

Any of these apparatuses may include a fluid transfer manifoldconnecting the storage chamber, the first delivery chamber, the seconddelivery chamber, and the delivery port.

The device may be configured to deliver fluid with fluid pressure of atleast 100 psi, or at least 150 psi at the delivery port while deliveringat least 30 mls fluid, at least 45 mls fluid, at least 60 mls fluid, orat least 100 mls fluid through the fluid manifold.

The device may be configured to deliver fluid through the fluid transfermanifold from 0.5 cc/second to 8 cc per second, or from 1 cc/second to 5cc/second.

In some examples, the device may include one or more sensors and acontroller (e.g., microcontroller) configured to determine an expulsionparameter. For example, the expulsion parameter may correspond to thenumber of times the first and/or second delivery chamber has beenfilled, the number of times the first and/or second delivery chamber hasbeen filled emptied, a volume of fluid removed from the device, or avolume of a fluid remaining in the device. In any of these devices, thesensor may comprise a quadrature encoder. Any of these apparatuses mayinclude a limit switch configured to stop device fluid delivery.

In any of these examples, a part of the first fluidic pathway and thesecond fluidic pathway may be part of the same pathway.

The volume of the storage chamber may be from 15 ml to 175 ml, from 30ml to 140 ml, and/or from 40 ml to 80 ml, etc. The volume of the storagechamber may be larger than the volume of either or both of the firstinjection chamber and the second injection chamber. In any of theseapparatuses, an inner diameter of the first and/or second deliverychamber may be less than 12.1 mm inner diameter, less than 8.9 mm innerdiameter, less than 6.5 mm inner diameter, or less than 4.9 mm innerdiameter, etc.

The storage chamber and/or the first delivery chamber and/or the seconddelivery chamber may comprise a syringe. The syringe may beremovable/replaceable. Any of these apparatuses may include an injectionneedle for fluidically connecting to the output port.

As mentioned, any of these apparatuses may include a controller (e.g., amicrocontroller) configured to control the drive system. In someexamples the flow rate and/or pressure may be regulated at least in partby the controller. In some examples, the apparatus may be configured tocontrol the flow rate, and/or maintain a constant flow rate and/orconstant pressure, by pre-pressurizing the delivery chamber(s) beforethey are opened for delivering fluid. Thus, any of these methods andapparatuses may include pre-pressurizing (and/or monitoring pressure in)the delivery chambers as part of the reciprocal filling/ejecting cycle.

As mentioned, also described herein are methods of expelling a fluidfrom an automatic expulsion device, comprising: continuously expelling afluid from out of delivery port of a hand-held device while triggering acontrol on the device by alternately: ejecting fluid from out of a firstdelivery chamber of an automatic expulsion device out of the deliveryport at 100 psi or more while filling a second delivery chamber withfluid from a fluid storage chamber of the automatic expulsion device andejecting fluid from out of a second delivery chamber of the automaticexpulsion device out of the delivery port at 100 psi or more whilefilling the first deliver chamber with fluid from the fluid storagechamber.

Any of these methods may include repeating the expelling and fillingsteps at least two times, at least five times, or at least ten times,etc. Any of these methods may include measuring or determining anexpulsion parameter using a sensor of the automatic expulsion device.

In general, the expulsion parameter may correspond to a number of timesthe first and/or second delivery chamber has been filled, emptied ormoved, a volume of fluid removed from the device, a volume of a fluidremaining in the device, or a fluid pressure. A fluid pressure in afluid manifold of the device may be between 3 psi and 500 psi, orbetween 5 psi and 250 psi, etc. Any of these methods may includemeasuring a fluid pressure of the fluid with a fluid sensor in thedevice. Thus, any of these methods may include maintaining a pressureand/or flow rate out of the device. As mentioned, a diameter of thefirst delivery chamber may be less than 12.1 mm inner diameter, lessthan 8.9 mm inner diameter, less than 6.5 mm inner diameter, or lessthan 4.9 mm inner diameter, etc. The device may comprise a fluidtransfer manifold, the method further comprising delivering fluid havinga fluid pressure of at least 100 psi, or at least 150 psi in the fluidtransfer manifold.

Any of these methods may include delivering fluid through the fluidtransfer manifold from 0.5 cc/second to 8 cc per second, or from 1cc/second to 5 cc/second, etc.

In any of these methods and apparatuses, the drive system may comprise amotor and a pulley or a roller, and expelling and filling may furthercomprise rotating the motor and engendering relative motion between thepulley or roller and the first and/or second delivery chambers, toalternately expel and fill the first delivery chamber and the seconddelivery chamber with fluid. Further, any of these methods may includeinserting a hollow sharp needle coupled to the delivery port into afirst tissue of a patient. Expelling may include expelling the fluidinto a subject through the hollow sharp needle, and/or stoppingexpelling, moving the hollow sharp needle into a second tissue of thepatient, and resuming expelling. This may be repeated (e.g., repeatingthe stopping step) at least one time, at least two times, at least fivetimes, at least ten times or at least twenty times, etc. Any of thesemethods may further include taking a tissue sample from a patientthrough the hollow sharp needle and determining if the tissue sample isa blood sample and removing the hollow sharp needle from the patientwithout expelling fluid if the tissue sample is a blood sample.

The automatic expulsion device may include a battery or a mechanicalenergy storage component, the method further comprising powering theexpelling and filling steps using the battery or mechanical energystorage component. For example, the automatic expulsion device maycomprise a mechanical energy storage component, further comprisingmanually charging the mechanical energy storage component by moving alever on the automatic expulsion device.

For example, described herein are apparatuses (e.g., devices andsystems) for injecting a fluid (e.g., a medication, including but notlimited to viscus or highly viscus fluids). These devices are hand-heldand do not require the use of additional cord/connectors. These devicesmay include multiple operational modes, including filling, injecting andaspirating. In the injecting mode, the device may be configured to runcontinuously (“freestyle”) or inject a predefined volume of fluid (e.g.,1 cc, 2 cc, 3 cc, 5 cc, 10 cc, etc.).

An apparatus (e.g., a system, a device, etc.) for injecting a fluid mayinclude: a reservoir; a first piston chamber fluidically connected tothe reservoir through a manifold; a second piston chamber fluidicallyconnected to the reservoir through the manifold; a plurality of checkvalves in the manifold; a delivery port fluidically connected to thefirst piston chamber and the second piston chamber through the manifold;a drive assembly comprising a transmission operatively connected to afirst piston in the first piston chamber and a second piston in thesecond piston chamber, wherein the drive assembly reciprocally moves thefirst piston and the second piston to drive fluid in a continuous flowout of the delivery port by alternately driving fluid from the secondpiston chamber and the first piston chamber out of the delivery portwhile alternately transferring fluid from the reservoir into the firstpiston chamber and the second piston chamber; a motor coupled to thedrive assembly; and a trigger control configured to activate the motor.

The apparatus may include one or more housings enclosing all or some ofthe components. For example, the apparatus may include a housingcomprising a grip region configured to be held in a user's hand. Thegrip region may be shaped to fit and held into the palm of the user'shand (either left or right hand) and may be generally cylindrical. Insome examples the apparatus has two or more portions (such as afluid-handling portion and a handle portion) that are connected togetherto form the apparatus (e.g., the device); each of these portions mayinclude a housing at least partially enclosing components specific toeach portion. For example, the handle portion may include a housingconfigured as a grip, as mentioned, and may include a control (e.g.,trigger control) that the user may actuate. The handle portion or thefluid-handling portion may include a control (e.g., a fluid volumecontrol) that the user may adjust to select between one or morepredetermined delivery volumes and/or a continuous delivery mode inwhich fluid is delivery continuously while the trigger control isactivated by the user.

In general, the apparatuses (e.g., devices) described herein may beconfigured to deliver fluid from the reservoir at relatively highpressure so as to be able to inject into body tissue that are otherwiseresistant to injection. For example, the apparatuses described herein beconfigured, including the structure and/or arrangement of the manifold,the first piston chamber and the second piston chamber, to drive fluidin the continuous flow at 100 psi or more from the delivery port. Ingeneral, the first and second piston chambers may be sized so that theyare relatively smaller volume (e.g., 1 cc, 2 cc, 3 cc, 5 cc, etc.) andcommunicate with the manifold through a small diameter (e.g., 5 mm orless, 4 mm or less, 3 mm or less, 2 mm or less, 1 mm or less) opening.Force is applied by the motor actuating the drive system so that thepistons within each piston chamber are moved in and out reciprocally, sothat as one is moved into the piston chambers, the other is moved out ofthe piston chambers. The movement of the motor may be constant orvariable. As will be described below in greater detail in some cases themovement of the motor (the rate) and therefore the movement of the drivesystem and pistons, may be adjusted based on the user actuation of thetrigger control.

Any of these apparatuses (e.g., devices) may include a selector that maybe coupled to the manifold and may be configured to select between aninjection configuration of the manifold, a filling configuration of themanifold and an aspiration configuration of the manifold. In theinjection configuration, the delivery port is in fluid communicationwith the first piston chamber and the second piston chamber. In thefilling configuration the delivery port is closed (manually and/orautomatically) and the reservoir is in fluid communication with a fillport. In the aspiration configuration the deliver port is in fluidcommunication with the fill port through the manifold.

As mentioned, any of these apparatuses may include a fluid volumecontrol configured to select between one or more predetermined deliveryvolumes or a continuous mode. The device may deliver a volume of fluidbased on a setting of the fluid volume control when a user actuates thetrigger control. In some examples the fluid volume control is on thehandle portion; in some examples the fluid volume control is on thefluid-handling portion. In some examples the controller controls themotor to deliver a volume of fluid based on a setting of the fluidvolume control when a user actuates the trigger control.

Any of these apparatuses (e.g., devices) may include on or moreindicators for indicating a status of the apparatus. For example, anindicator may be configured to indicate that the power is on/active. Thesame of a different indicator may indicate that a two (or more)component device is fully connected/assembled. The same of a differentindicator may indicate that the reservoir is empty or not empty (and insome cases may indicate an approximate volume of fluid remaining in thereservoir or in the reservoir and piston chambers). The same or adifferent indicator may indicate that the pressure within the device(e.g., within the manifold) is above or below one or more thresholds.For example, any of these apparatuses (e.g., devices) may) include anindicator indicating when the reservoir is empty. For example, theapparatus may include an indicator may indicate when a pressure withinthe manifold exceeds a threshold value.

The apparatuses described herein may also include a pressure reliefvalve. For example, the apparatus may include a pressure relief value inthe manifold.

The manifold is described in greater detail herein and may be configuredin any of these apparatuses to be compact. The manifold may beconfigured to change configuration, as mentioned above, to switchbetween two or more different modes of operation, such as filling,injecting and aspirating. For example, in some cases the manifold may beconfigured to include a plurality of vales to direct fluid within thevalve. Any of the valves described herein may be check valves. Forexample any of these apparatuses may include a manifold that includes afirst check valve and a second check valve that are fluidly coupled toan input to the first piston chamber so that when the manifold is in aninjection configuration fluid is passed from the reservoir into thefirst piston chamber as the first piston is withdrawn in the firstpiston chamber and fluid is passed from the first piston chamber out ofthe delivery port when the first piston is advanced in the first pistonchamber, wherein the manifold is further configured so that a thirdcheck valve and a fourth check valve are fluidly coupled to an input tothe second piston chamber so that in when the manifold is in theinjection configuration fluid is passed from the reservoir into thesecond piston chamber as the second piston is withdrawn in the secondpiston chamber and fluid is passed from the second piston chamber out ofthe delivery port when the second piston is advanced in the secondpiston chamber.

In general, the apparatuses described herein may be configured so thatthey may include or be adapted to couple to a needle. For example, anyof these apparatuses may include a delivery port is configured to coupleto a needle, e.g., the delivery port may be threaded, or may beconfigured to couple with a Luer-Lock fitting.

For example, a device for injecting a fluid may include a housing; areservoir comprising a bag at least partially within the housing; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a delivery port fluidically connected to the firstpiston chamber and the second piston chamber through the manifold; adrive assembly comprising a transmission operatively connected to afirst piston in the first piston chamber and a second piston in thesecond piston chamber, wherein the drive assembly reciprocally moves thefirst piston and the second piston; wherein the manifold is configuredso that a first check valve and a second check valve are fluidly coupledto an input to the first piston chamber so that in when the manifold isin an injection configuration, fluid is passed from the reservoir intothe first piston chamber as the first piston is withdrawn in the firstpiston chamber and fluid is passed from the first piston chamber out ofthe delivery port when the first piston is advanced in the first pistonchamber, wherein the manifold is further configured so that a thirdcheck valve and a fourth check valve are fluidly coupled to an input tothe second piston chamber so that when the manifold is in the injectionconfiguration, fluid is passed from the reservoir into the second pistonchamber as the second piston is withdrawn in the second piston chamberand fluid is passed from the second piston chamber out of the deliveryport when the second piston is advanced in the second piston chamber; amotor coupled to the drive assembly; and a trigger control configured toactivate the motor.

For example, described herein are apparatuses (e.g., devices) forinjection of a fluid that include: a reservoir; a manifold comprising aplurality of check valves; a fill port fluidly connected to, or part of,the manifold; a first piston chamber fluidically connected to themanifold; a second piston chamber fluidically connected to the manifold;a drive assembly coupled to a first piston in the first piston chamberand a second piston in the second piston chamber; a delivery portfluidically connected to the manifold; a selector having a firstposition and a second position; and a spool (also referred to herein asa spool valve) within the manifold that is translationally coupled tothe selector, so that: when the selector is in the first position, thedelivery port is in fluid communication with the first piston chamber,the second piston chamber and the reservoir through the plurality ofcheck valves so that as the drive assembly reciprocally drives the firstpiston and the second piston, fluid is alternately transferred from thereservoir and into the first piston chamber and the second pistonchamber, and fluid is alternately driven from the second piston chamberand the first piston chamber and out of the delivery port, and when theselector is in the second position the reservoir is in fluidcommunication with the fill port.

Any of these apparatuses may be configured so that the selector includesa third position, and wherein when the selector is in the third positionthe delivery port is in fluid communication with the fill port and thereservoir, first piston chamber and second piston chamber are not influid communication with the delivery port.

As mentioned above, comprising an overpressure valve within the manifoldconfigured to open when a pressure within the manifold exceeds athreshold value. In some cases, the apparatus may include a pressuresensor within the manifold configured to emit one or more alerts whenthe pressure sensor detects a pressure greater than a first thresholdvalue or less than a second threshold value. For example, any of theseapparatuses may include a pressure sensing chamber within the manifoldcomprising one or more biases configured to deflect a magnet within thepressure sensing chamber based on a pressure within the manifold.

In general, the manifold may be compact. For example, the manifold maybe configured to have a length of about 5 cm or less (e.g., less than 5cm, 4 cm or less, 3 cm or less, etc.) and height of about 6 cm or less(e.g., less than 6 cm, 5 cm or less, 4 cm or less, 3 cm or less, etc.).

In some examples the apparatus (e.g., device) includes a housing atleast partially enclosing the manifold, and/or reservoir, and/or firstpiston chamber and/or second piston chamber. In some examples thishousing may be a first housing, also referred to herein in some examplesas an upper housing; this first housing may be coupled to a secondhousing (e.g., a lower housing). For example, the housing may beconfigured to couple with a hand-held base comprising a power supply anda motor so that the drive assembly engages with the motor to reciprocatethe first piston and the second piston.

As mentioned, any of these apparatuses may include a control forselecting the mode of operation of the apparatus, and in particular foradjusting the state of the manifold. This control may be referred toherein as a selector. In some examples, the selector comprises a camdriving axial movement of the spool within the manifold.

For example, a device for injection of a fluid may include: a reservoir;a manifold comprising a plurality of check valves; a fill port fluidlyconnected to, or part of, the manifold; a first piston chamberfluidically connected to the manifold; a second piston chamberfluidically connected to the manifold; a drive assembly coupled to afirst piston in the first piston chamber and a second piston in thesecond piston chamber; a delivery port fluidically connected to themanifold; a selector having a first position, a second position, and athird position; and a spool (e.g., spool valve) within the manifold thatis translationally coupled to the selector, so that: when the selectoris in the first position, the delivery port is in fluid communicationwith the first piston chamber, the second piston chamber and thereservoir through the plurality of check valves so when that the driveassembly reciprocally drives the first piston and the second piston,fluid is alternately transferred from the reservoir and into the firstpiston chamber and the second piston chamber and fluid is alternatelydriven from the second piston chamber and the first piston chamber outof the delivery port in a continuous flow, when the selector is in thesecond position, the reservoir is in fluid communication with the fillport, and when the selector is in the third position, the delivery portis in fluid communication with the fill port, and the reservoir, thefirst piston chamber and the second piston chamber are not in fluidcommunication with the delivery port.

In some examples an apparatus (e.g., a device) for injection of a fluidmay include: a reservoir; a manifold comprising a plurality of checkvalves; a fill port fluidly connected to, or part of, the manifold; afirst piston chamber fluidically connected to the manifold; a secondpiston chamber fluidically connected to the manifold; a drive assemblycoupled to a first piston in the first piston chamber and a secondpiston in the second piston chamber; a delivery port fluidicallyconnected to the manifold; a selector having a first position, a secondposition, and a third position; a spool within the manifold that istranslationally coupled to the selector, so that: when the selector isin the first position, the spool is moved relative to the manifold sothat the delivery port is in fluid communication with the first pistonchamber, the second piston chamber and the reservoir through theplurality of check valves so that when that the drive assemblyreciprocally drives the first piston and the second piston, fluid isalternately transferred from the reservoir and into the first pistonchamber and the second piston chamber and fluid is alternately drivenfrom the second piston chamber and the first piston chamber out of thedelivery port in a continuous flow, when the selector is in the secondposition, the spool is moved so that the reservoir is in fluidcommunication with the fill port, and when the selector is in the thirdposition, the spool is moved relative to the manifold so that thedelivery port is in fluid communication with the fill port, and thereservoir, the first piston chamber and the second piston chamber arenot in fluid communication with the delivery port; a pressure sensorwithin the manifold; and an indictor configured to emit one or morealerts when the pressure sensor detects a pressure greater than a firstthreshold value or less than a second threshold value.

Also described herein are methods of using any of the apparatusesdescribed herein. For example, a method of injecting a fluid mayinclude: maintaining a selector of a hand-held injection device to afirst position so that a delivery port of the hand-held injection deviceis closed and a reservoir within the hand-held injection device is influid communication with a fill port; applying the fluid into thereservoir through the fill port of the hand-held injection device;moving the selector of the hand-held injection device to a secondposition so that the delivery port is in fluid communication with afirst piston chamber of the hand-held injection device, a second pistonchamber of the hand-held injection device and the reservoir through aplurality of check valves; and engaging a drive assembly of thehand-held injection device when a user engaged a trigger of thehand-held injection device while the selector is in the second positionto reciprocally drive a first piston in the first piston chamber and asecond piston in the second piston chamber to alternately transfer fluidfrom the reservoir and into the first piston chamber and the secondpiston chamber, and to alternately drive fluid from the second pistonchamber and the first piston chamber out of the delivery port in acontinuous flow.

Maintaining the selector of the hand-held injection device in the firstposition may include receiving the device with the selector already inthe first position, or it may include moving the selector into the firstposition, or it may include confirming (e.g., by visual inspection orthe like) that the selector is in the first position.

Any of these methods may include aspirating fluid through the device(e.g., from a needle attached to the tip). Any of these methods mayinclude moving a selector of the hand-held injection device to a thirdposition so that the delivery port is in fluid communication with thefill port, and the reservoir, the first piston chamber and the secondpiston chamber are not in fluid communication with the delivery port.For example, the methods described herein may include applying suctionon the fill port to aspirate fluid from the delivery port when theselector is in the third position.

For example, a method may include coupling a handle portion of thehand-held injection device to a fluid-handing portion of the hand-heldinjection device, wherein the fluid-handing portion comprises thedelivery port, the fill port, the reservoir, the first piston chamberand the second piston chamber, and wherein the handle portion comprisesa power source and a motor.

The methods described herein may include assembling the apparatus from afluid-handing component and a handle component. For example, any of themethods may include coupling by mechanically coupling the motor with adrive assembly in the fluid-handing portion, wherein the drive assemblycouples to a first piston in the first piston chamber and a secondpiston in the second piston chamber to reciprocally drive the firstpiston and the second piston.

In any of these methods moving the selector of the hand-held injectiondevice to the first position may comprise translating a spool in amanifold of the hand-held injection device.

Also described herein are apparatuses (and methods for using them) thatallow a user (e.g., doctor, surgeon, nurse, assistant, etc.) to controlthe rate at which fluid is applied by the apparatus, and/or the force orpressure that fluid is applied, based on the force applied to thetrigger control (or another control). This may be particularly usefulwhen the apparatus is operated in the continuous (e.g., “freestyle”)mode of operation. For example, described herein are apparatuses (e.g.,devices) for injecting a fluid, the device comprising: a reservoir; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; a drive assembly comprisinga transmission operatively connected to a first piston in the firstpiston chamber and a second piston in the second piston chamber, whereinthe drive assembly reciprocally moves the first piston and the secondpiston to drive fluid in a continuous flow out of the delivery port byalternately driving fluid from the second piston chamber and the firstpiston chamber out of the delivery port while alternately transferringfluid from the reservoir into the first piston chamber and the secondpiston chamber; a motor coupled to the drive assembly; a housingcomprising a grip region configured to be held in a user's hand; atrigger control comprising a trigger sensor configured to detect forceapplied to the trigger control; and a controller, wherein the controlleris configured to adjust a rate of the motor based on the force appliedto the trigger control.

In some examples the trigger sensor comprises a force sensitiveresistor. In some examples, the trigger sensor comprises a pressuresensor. In some examples the trigger control comprises a lever.Alternatively in some examples a separate control on the apparatus(either the handle portion of the fluid-handling portion) may beconfigured to adjust the rate at which fluid is applied by controllingthe rate of movement of the motor and therefore of the drive assembly(and pistons).

As mentioned, any of these apparatuses may include a selector coupled tothe manifold and configured to select between an injection configurationof the manifold, a filling configuration of the manifold and anaspiration configuration of the manifold, wherein in the injectionconfiguration the delivery port is in fluid communication with the firstpiston chamber and the second piston chamber, wherein in the fillingconfiguration the delivery port is closed and the reservoir is in fluidcommunication with the fill port, and wherein in the aspirationconfiguration the delivery port is in fluid communication with the fillport through the manifold.

Any of these apparatuses may include a fluid volume control configuredto select between one or more predetermined delivery volumes (e.g., 1cc, 2 cc, 3 cc, 4 cc, 5 cc, 6 cc, 7 cc, 8 cc, 9 cc, 10 cc, 15 cc, etc.)and a continuous mode; the controller may control the motor to deliver avolume of fluid based on a setting of the fluid volume control when theuser actuates the trigger control. For example, the controller may beconfigured to adjust the rate of the motor based on the force applied tothe trigger control when the fluid volume control is in the continuousmode.

As mentioned, any of these apparatuses may include an indicatorindicating when the reservoir is empty, and/or a pressure relief valuein the manifold. Any of these apparatuses may include an indicatorindicating when a pressure within the manifold exceeds a thresholdvalue. The manifold may be configured so that a first check valve and asecond check valve are fluidly coupled to an input to the first pistonchamber so that when the manifold is in an injection configuration fluidis passed from the reservoir into the first piston chamber as the firstpiston is withdrawn in the first piston chamber and fluid is passed fromthe first piston chamber out of the delivery port when the first pistonis advanced in the first piston chamber, wherein the manifold is furtherconfigured so that a third check valve and a fourth check valve arefluidly coupled to an input to the second piston chamber so that in whenthe manifold is in the injection configuration fluid is passed from thereservoir into the second piston chamber as the second piston iswithdrawn in the second piston chamber and fluid is passed from thesecond piston chamber out of the delivery port when the second piston isadvanced in the second piston chamber.

For example, a device for injecting a fluid may include: a reservoir; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; a drive assembly comprisinga transmission operatively connected to a first piston in the firstpiston chamber and a second piston in the second piston chamber, whereinthe drive assembly reciprocally moves the first piston and the secondpiston to drive fluid in a continuous flow out of the delivery port byalternately driving fluid from the second piston chamber and the firstpiston chamber out of the delivery port while alternately transferringfluid from the reservoir into the first piston chamber and the secondpiston chamber; a motor coupled to the drive assembly; a housingcomprising a grip region configured to be held in a user's hand; atrigger control comprising a trigger sensor configured to detect forceapplied to the trigger control; a fluid volume control configured toselect between one or more predetermined delivery volumes and acontinuous mode; and a controller, wherein the controller is configuredto adjust a rate of the motor based on the force applied to the triggercontrol when the fluid volume control is set to the continuous mode.

Any of these apparatuses may be configured as two (or more) componentdevices that may be assembled together by the user (or another) prior tousing the apparatus. For example, in some cases the combined apparatus(e.g., a system or device) may include a first fluid-handling portionthat coupled to a second handle portion. The two may engage with eachother so that a power source and driver (e.g., motor) in the handleportion engages with the drive system in the fluid-handling portion.

In some cases one component (e.g., the fluid handling component) isdisposable or single-patient use, while the handle portion may bereusable (e.g., with different patients). Any of these apparatuses(e.g., devices or systems) for injecting a fluid may include: afluid-handing portion and a handle portion that are coupled together foruse. The assembled apparatus may also and equivalently be referred to asa system or as a device; in addition, the individual fluid-handlingcomponent may be referred to as a sub-assembly or as a device.

For example, described herein are systems for injecting a fluid, thesystem comprising: a fluid-handing portion comprising: a reservoir; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; a drive assembly comprisinga transmission operatively connected to a first piston in the firstpiston chamber and a second piston in the second piston chamber, whereinthe drive assembly reciprocally moves the first piston and the secondpiston to drive fluid in a continuous flow out of the delivery port byalternately driving fluid from the second piston chamber and the firstpiston chamber out of the delivery port while alternately transferringfluid from the reservoir into the first piston chamber and the secondpiston chamber; a first housing at least partially covering thereservoir, manifold, first piston chamber and second piston chamber; anda handle portion comprising: a motor coupled to the drive assembly; atrigger control configured to activate the motor; and a second housingcomprising a grip region configured to be held in a user's hand, whereinthe handle portion and the fluid-handling portion are configured toreleasably couple so that the motor engages with the drive assembly toreciprocate the first piston and the second piston.

Any of these apparatuses may include a securement to hold two (or more)components, such as the fluid-handling portion and the handle portion,together. For example, any of these apparatuses may include a latchconfigured to releasably secure the fluid-handing portion to the handleportion. The securement may include a lock. In some examples the two (ormore) components may be permanently coupled together or may betemporarily (e.g., releasably) coupled together.

In general, the apparatuses described herein may include one or moresensors, such as pressure sensors, that may monitor and react topressure within the apparatus, and particularly within the manifold,such as by applying a warning, releasing a pressure release valve,triggering an alert, etc. For example, any of these apparatuses (e.g.,systems) described herein may include a magnet within the manifold ofthe fluid-handling portion configured to move relative to an internalfluid pressure within the manifold, wherein the handle portion comprisesa magnetic sensor configured to detect a position or a change inposition of the magnet.

In some examples the fluid-handling portion may include a selectorcoupled to the manifold and configured to select between an injectionconfiguration of the manifold, a filling configuration of the manifoldand an aspiration configuration of the manifold, wherein in theinjection configuration the delivery port is in fluid communication withthe first piston chamber and the second piston chamber, wherein in thefilling configuration the delivery port is closed and the reservoir isin fluid communication with a fill port, and wherein in the aspirationconfiguration the delivery port is in fluid communication with the fillport through the manifold.

In some examples the apparatus may include a fluid volume control on thehandle portion configured to select between one or more predetermineddelivery volumes or a continuous mode, wherein the system delivers avolume of fluid based on a setting of the fluid volume control when theuser actuates the trigger control.

In some examples, the handle portion comprises a fluid volume controlselectable by the user and configured to select between one or morepredetermined delivery volumes and a continuous mode, and a controller,wherein the controller controls the motor to deliver a volume of fluidbased on a setting of the fluid volume control when the user actuatesthe trigger control.

As mentioned, any of these apparatuses may include a manifold that isconfigured so that a first check valve and a second check valve arefluidly coupled to an input to the first piston chamber so that when themanifold is in an injection configuration fluid is passed from thereservoir into the first piston chamber as the first piston is withdrawnin the first piston chamber and fluid is passed from the first pistonchamber out of the delivery port when the first piston is advanced inthe first piston chamber, wherein the manifold is further configured sothat a third check valve and a fourth check valve are fluidly coupled toan input to the second piston chamber so that in when the manifold is inthe injection configuration fluid is passed from the reservoir into thesecond piston chamber as the second piston is withdrawn in the secondpiston chamber and fluid is passed from the second piston chamber out ofthe delivery port when the second piston is advanced in the secondpiston chamber.

The apparatuses described herein may be operated as part of a surgicalor non-surgical, including cosmetic indications. For example, althoughthe majority of the examples described herein may be used to apply amedication to a patient (human and non-human patients, includinganimals), these apparatuses and methods may also or alternatively beused to apply a fluid to plants and other organisms. These apparatusesmay be used to apply fluid (including in particular a viscus fluid) aspart of any method that would benefit from the controlled injection offluid.

For example, described herein are methods, comprising: assembling afluid-handing portion of an injection system with a handle portion ofthe injection system by coupling the fluid-handling portion to thehandle portion so that a motor in the handle portion engages a driveassembly in the fluid-handling portion; filling a reservoir within thefluid-handling portion with a fluid while a selector on thefluid-handling portion is set to a fill position so that a manifoldwithin the fluid-handling portion is in a fill configuration with thereservoir in fluid communication with a fill port on the fluid-handlingportion through the manifold; setting the selector on the fluid-handingportion to an injection position so that the manifold is in an injectionconfiguration in which a delivery port of the fluid-handing portion isin fluid communication with a first piston chamber, a second pistonchamber and the reservoir through a plurality of check valves; andejecting fluid from the delivery port when a trigger control on thehandle portion is activated by activating the motor so that the driveassembly reciprocally drives a first piston in the first piston chamberand a second piston in the second piston chamber to alternately transferfluid from the reservoir and into the first piston chamber and thesecond piston chamber, and to alternately drive fluid from the secondpiston chamber and the first piston chamber out of the delivery port ina continuous flow. In some examples, assembling the fluid-handlingportion turns on power to the injection system.

Any of these methods may include attaching an injection needle to thedelivery port (e.g., via a Lure lock attachment on the delivery port).Any of these methods may include setting the selector to a fill positionprior to filling the reservoir. Fluid may be filled by applying (e.g.,from a syringe or other connector attached to the fill port on theapparatus (e.g., on the fluid-handling portion, coupled to themanifold). In one example a 60 cc syringe of fluid material to beinjected with the device may be loaded via the fill port (via a Luerlock connector). When filling the delivery port may be closed,automatically (e.g., by the change in configuration of the manifold,e.g., by one or more valves, include a ball valve) and/or manually bycapping or closing the delivery port. For example, any of these methodsmay include closing the delivery port before filling the reservoir.Prior to injection, any of these methods may include priming theinjection system.

In some examples, the method includes setting a fluid volume control toa pre-set volume mode (e.g., to deliver a pre-set volume such as 1 cc, 2cc, 3 cc, etc.) or to a continuous delivery mode prior to ejecting fluidfrom the delivery port. The method of claim 62, wherein

In any of these methods, ejecting fluid from the delivery port mayinclude ejecting fluid to a predefined volume when a fluid volumecontrol is set to a predefined volume mode. In some examples, ejectingfluid to the predefined volume comprises encoding movement of the driveassembly and comparing the encoded movement to a predefined value. Insome examples ejecting fluid from the delivery port comprises adjustinga rate of movement of the drive assembly based on force applied to thetrigger control. For example, ejecting fluid from the delivery port maycomprise continuously ejecting fluid from the delivery port while thetrigger control is activated by a user.

Any of the methods may include ejecting fluid from the delivery port byreciprocating the motor so that the motor is driven alternatelyclockwise and counterclockwise. The reciprocating movement of the motormay thus drive the drive assembly (e.g., a pulley, belt, etc.) in areciprocating manner to move the attached pistons in and out of theirrespective piston chambers.

Any of these methods may include setting the selector on thefluid-handing portion to an aspiration position so that the manifold isin an aspiration configuration in which the delivery port is in fluidcommunication with the fill port and the reservoir, the first pistonchamber and the second piston chamber are not in fluid communicationwith the delivery port. For example, these methods may includeaspirating through the injection system by applying suction to the fillport.

Thus, described herein are methods comprising: filling a reservoirwithin a hand-held injection system with a fluid while a selector on thehand-held injection system is set to a fill position so that a manifoldwithin the hand-held injection system is in a fill configuration withthe reservoir in fluid communication with a fill port on the hand-heldinjection system through the manifold; setting the selector to aninjection position so that the manifold is in an injection configurationin which a delivery port of the hand-held injection system is in fluidcommunication with a first piston chamber, a second piston chamber andthe reservoir through a plurality of check valves; and ejecting fluidfrom the delivery port when a trigger control on a handle of thehand-held injection system is activated so that a drive assemblyreciprocally drives a first piston in the first piston chamber and asecond piston in the second piston chamber to alternately transfer fluidfrom the reservoir and into the first piston chamber and the secondpiston chamber, and to alternately drive fluid from the second pistonchamber and the first piston chamber out of the delivery port in acontinuous flow.

In some examples, the reservoir of any of the apparatuses describedherein may be configured as a collapsible/conformable bag. The bag maybe biased within a housing of the apparatus so that there is a pressureapplied to drive the fluid out of the reservoir, even when not activelypumped (e.g., by the action of the piston movement in the pistonchambers). This may help assist the apparatus in injecting fluid and inrapidly reloading the piston chambers.

For example, described herein are apparatuses in which the reservoircomprises a bag and a foam material arranged against the bag to providea compressive force. In some examples the device includes: a housing; areservoir comprising a bag at least partially within the housing; acompressible foam within the housing and adjacent to the reservoir, andconfigured to apply a compressive force to collapse the reservoir; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a delivery port fluidically connected to the firstpiston chamber and the second piston chamber through the manifold; adrive assembly comprising a transmission operatively connected to afirst piston in the first piston chamber and a second piston in thesecond piston chamber, wherein the drive assembly reciprocally moves thefirst piston and the second piston; wherein the manifold is configuredso that a first check valve and a second check valve are fluidly coupledto an input to the first piston chamber so that in when the manifold isin an injection configuration, fluid is passed from the reservoir intothe first piston chamber as the first piston is withdrawn in the firstpiston chamber and fluid is passed from the first piston chamber out ofthe delivery port when the first piston is advanced in the first pistonchamber, wherein the manifold is further configured so that a thirdcheck valve and a fourth check valve are fluidly coupled to an input tothe second piston chamber so that when the manifold is in the injectionconfiguration, fluid is passed from the reservoir into the second pistonchamber as the second piston is withdrawn in the second piston chamberand fluid is passed from the second piston chamber out of the deliveryport when the second piston is advanced in the second piston chamber. Insome examples the compressive foam is an open cell foam. The reservoirmay be driven against the housing by the compressible foam.

These apparatuses may include any of the features described above. Forexample, the apparatus (e.g., device) may include a selector on thehousing having a first position and second position, wherein theselector is configured to transition the manifold between the injectionconfiguration corresponding to the first position and a fillconfiguration corresponding to the second position, wherein in the fillconfiguration the reservoir is in fluid communication with a fill portin fluid communication with the manifold. The device of may include anoverpressure valve within the manifold configured to open when apressure within the manifold exceeds a threshold value. In someexamples, the device may include a pressure sensor within the manifoldconfigured to emit one or more alerts when the pressure sensor detects apressure greater than a first threshold value or less than a secondthreshold value. For example, the device may include a pressure sensingchamber within the manifold comprising one or more biases configured todeflect a magnet within the pressure sensing chamber based on a pressurewithin the manifold.

In some examples a device for injecting a fluid may include: a housing;a reservoir comprising a bag at least partially within the housing; acompressible foam within the housing and adjacent to the reservoir, andconfigured to apply a compressive force to collapse the reservoir; afirst piston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; and a drive assemblycomprising a transmission operatively connected to a first piston in thefirst piston chamber and a second piston in the second piston chamber,wherein the drive assembly reciprocally moves the first piston and thesecond piston to drive fluid in a continuous flow out of the deliveryport by alternately driving fluid from the second piston chamber and thefirst piston chamber out of the delivery port while alternatelytransferring fluid from the reservoir into the first piston chamber andthe second piston chamber.

Thus, in general, the apparatuses described herein may include devicesfor injecting a fluid that include: a reservoir; two or more pistonchamber fluidically connected to a reservoir through a manifold and tothe reservoir, and a drive assembly and motor for driving the injectionof fluid from the two or more piston chambers into the manifold and outof a delivery port (to which an needle may be attached). The device mayalso include a handle with a control to actuate the device (such as atrigger control). Any of these devices may include a controller that maycontrol activation of the device. The manifold may be configured withvalves for switching between the two or more piston chambers so that acontinuous flow out of the delivery port may be achieved. In someexamples the device may include a control (switch, lever, etc.) forswitching between a continuous mode or a pre-set volume delivery mode.Any of these device may include a control for switching betweeninjection/injecting, re-filling of the reservoir, and in some examples,aspirating from the injection port.

Also described herein are apparatuses (devices and systems) in which thedrive assembly includes a belt coupled to the pistons to alternatelydrive and retract the pistons of the piston chambers. The belt may be achain, wire, robe, etc. The belt let may be reciprocated (e.g., drivenin a first direction, then a second direction, based on the gearingand/or under control of a controller. The controller may control theoperation (and/or direction of rotation) of one or more motors.

Any of the apparatuses described herein may include one or moreregistration checkpoints as described herein. The registration checkpoints may be used for tracking and/or controlling movement and/oroperation of the apparatus. For example, one or more registrationcheckpoints may be present on the front, back, left side, right side,top and/or bottom.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative examples, inwhich the principles of the invention are utilized, and the accompanyingdrawings of which:

FIG. 1A shows a side perspective view of one example of an injectionapparatus as described herein.

FIG. 1B shows a front perspective view of the injection apparatus shownin FIG. 1A.

FIG. 1C shows a back perspective view of the injection apparatus shownin FIG. 1A.

FIG. 1D shows an example of locations for injections into a knee joint.

FIG. 2A shows a partially transparent side view of an example of aninjection apparatus.

FIG. 2B shows a partial side cross-sectional of the injection apparatusshown in FIG. 2A.

FIG. 3A shows a partial top perspective view of part of the drive systemof the injection apparatus shown in FIG. 2A.

FIG. 3B shows a partial top cross-sectional view of the injectionapparatus shown in FIG. 2A.

FIG. 3C shows a partial top cross-sectional view of the apparatus shownin FIG. 3B with the batteries removed.

FIG. 3D shows a top cross-sectional view of the apparatus shown in FIG.3B with various components removed.

FIG. 3E shows a top cross-sectional view of the apparatus shown in FIG.3D with additional components removed.

FIG. 3F shows a partial end view of the proximal part of the of theinjection apparatus shown in FIG. 3E.

FIG. 3G shows a rear view of the proximal part of the of the injectionapparatus shown in FIG. 3E.

FIG. 3H shows a partial perspective view of the proximal part of the ofthe injection apparatus.

FIG. 3I shows a top perspective view of a carriage useful fortranslating part of a delivery chamber.

FIG. 3J shows a perspective view of the proximal end of the carriageshown in FIG. 3H.

FIG. 3K shows a side perspective view of a shaft configured to fit intothe carriage shown in FIG. 3H and FIG. 3I.

FIG. 3L shows a bottom perspective view of the injection apparatus shownin FIG. 2A with a motor and switches.

FIG. 4A shows a side perspective view of an example of an injectionapparatus.

FIG. 4B shows a partial side perspective view of part of the fluidtransfer system of the injection apparatus shown in FIG. 4A.

FIG. 4C shows a partial side perspective view of part of the distal partof the fluid transfer system of the injection apparatus shown in FIG.4A.

FIG. 4D shows a partial side perspective view of part of the distal partof the fluid transfer system of the injection apparatus shown in FIG. 4Awith the internal manifold piping removed.

FIG. 4E shows a partial side perspective view of part of the distal partof the fluid transfer system of the injection device shown in FIG. 1Awith the internal manifold piping removed.

FIG. 4F shows a partial side perspective view of part of the distal partof the fluid transfer system of the injection apparatus shown in FIG. 4Awith the fluid transfer manifold piping removed.

FIG. 4G shows a view of the fluid transfer manifold of the injectionapparatus shown in FIG. 4A.

FIG. 5A illustrates one portion of an interface of an apparatus asdescribed herein.

FIG. 5B illustrates a portion of an apparatus as described herein.

FIG. 6 illustrates an example of a portion of an actuator assembly asdescribed herein, showing one example of a selector control that may beused.

FIG. 7A shows a side schematic of part of a peristaltic fluid deliverysystem, including portions of an actuator assembly as described herein,showing a pressure driven (e.g., pump) mechanism including a pluralityof rollers acting on a compressible hose or tube.

FIG. 7B shows a side schematic of the peristaltic fluid delivery systemshown in FIG. 7A.

FIG. 7C shows a schematic cross-sectional view of the peristaltic fluiddelivery system shown in FIG. 7B.

FIG. 8 shows a side schematic of another peristaltic fluid deliverysystem.

FIG. 9 shows a top view of an apparatus similar to that shown in FIG.7A-7C.

FIG. 10A shows a side schematic of another peristaltic fluid deliveryapparatus.

FIG. 10B shows a schematic cross-sectional view of the peristaltic fluiddelivery system shown in FIG. 10A.

FIG. 10C shows examples of portions of an actuator assembly as describedherein.

FIG. 11 shows an example of a portion of an actuator assembly (alsoreferred to as a drive assembly) as described herein.

FIG. 12A shows a schematic side perspective view of a fluid delivery(injection) apparatus with a ratchet mechanism.

FIG. 12B shows another view of the fluid delivery (injection) apparatusshown in FIG. 12A.

FIG. 12C shows another view of the apparatus shown in FIG. 12A.

FIG. 13 shows another example of an injection apparatus with a ratchetmechanism.

FIG. 14 shows another example of an injection apparatus with apressurized fluid chamber.

FIG. 15A schematically illustrates one example of a method of operationa hand-held injection apparatus as described herein.

FIG. 15B schematically illustrates an example of a method of operatingan injection apparatus as described herein.

FIG. 16 is an example of a portion of an apparatus including a forcesensitive resistor integrated into the handle and configured to adjustthe flow rate.

FIG. 17 schematically illustrates another example of a portion of anapparatus as described herein.

FIGS. 18A-18C illustrate partially exploded views of one example of anapparatus for automatically injecting fluid (including highly viscousfluids) as described herein. FIG. 18A shows a front perspective view ofsome of the components of the apparatus. Other components are removed(such as the housing, storage chamber and fluid delivery chambers. FIG.18B shows a rear partially exploded view. FIG. 18C shows a frontperspective view in which a portion of the front housing has been madetransparent to show the configuration of the components within thisportion of the housing.

FIGS. 18D and 18E illustrate assembled views of the apparatus shown inFIGS. 18A-18C.

FIGS. 19A-19B illustrate examples of tissue injected with a dye solutionusing a prototype of one of the apparatuses as described herein. FIG.19A shows the results of injection with a 25 gauge needle. FIG. 19Bshows the results of an injection with a 22 gauge needle.

FIG. 20A is a side view of an example of an injection apparatus asdescribed herein.

FIGS. 20B-20D illustrate side perspective views of the injectionapparatus similar to that of FIG. 20A.

FIGS. 21A-21C illustrate front perspective, front plan and backperspective views, respectively, of one example of a manifold assembly(“manifold”) for an injection apparatus as described herein.

FIG. 21D is an exploded view of a manifold assembly similar to thatshown in FIGS. 21A-21C.

FIG. 22A shows an example of a manifold assembly and a magnetic positionsensor configured to detect pressure within the manifold assembly.

FIGS. 22B-22C show side perspective and sectioned views, respectively,of a portion of the pressure sensing assembly within a manifold assemblysimilar to that shown in FIG. 22A.

FIGS. 23A and 23B show side sectional views, respectively, of a manifoldassembly of an injection apparatus as described herein.

FIG. 24A shows an unassembled injection apparatus including a fluidhandling portion and a handle portion that may be assembled together toform a functional injection apparatus as described herein.

FIG. 24B shows the assembled injection apparatus of FIG. 24A.

FIGS. 25A, 25B and 25C show side, top and bottom plan views,respectively, of an injection apparatus.

FIG. 26 is an example of an injection apparatus similar to that shown inFIGS. 24A-24B and 25A-25C with the front of the housing over the handleand fluid handling portions removed.

FIG. 27A shows one example of a reservoir, configured as a collapsiblebag.

FIG. 27B shows an exploded view of the reservoir of FIG. 27A.

FIG. 28A illustrates one example of a drive assembly, driver,controller, and trigger control for an injection apparatus as describedherein.

FIG. 28B illustrates an example of a pair of piston chambers, pistonsand manifold that may be used with (e.g., coupling the pistons to thedrive assembly) the drive assembly of FIG. 28A.

FIG. 29 is an example of an injection apparatus similar to that shown inFIG. 24A including tracking markers for tracking the position and/ororientation of the apparatus during use.

FIGS. 30A-30C illustrate side perspective, side and bottom views,respectively, of another example of a portion of an injection apparatusas described herein.

FIG. 31 shows an example of a shuttle that may be used within aninjection apparatus similar to that shown in FIGS. 30A-30C.

FIG. 32A schematically illustrates one example of a fluid circuit for aninjection apparatus as described herein.

FIG. 32B schematically illustrates an example of a fluid circuit(including an aspiration port) as described herein.

FIG. 33 is a chart illustrating a method of preparing an injectionapparatus for use, including (optionally) assembling the apparatus,filling the apparatus and/or priming the apparatus.

FIG. 34 is a chart illustrating a method of operating an injectionapparatus as described herein, including selecting the mode of operation(e.g., injection), selecting continuous or preset volume injection,optionally confirming the position of the needle by aspiration, andinjecting material using the apparatus.

FIG. 35 is a chart illustrating a method of ending an injection session.

DETAILED DESCRIPTION

The apparatuses (e.g., devices, systems, etc., including in particularhigh-pressure injectors) described herein may inject a fluid, such as adrug and including, but not limited to, a viscus fluid, through asmall-gauge needle into material, including the tissues of a body. Theapparatus may provide the mechanical energy rejected to inject the fluidthereby reducing the operating force on the user's hand during aninjection. These apparatuses may also inject within a set pressurerange, and may inject a preset volume (e.g., 1 cc, 2 cc, 3 cc, 5 cc, 10cc, etc.) and/or continuously. The injection may be at a constant rateor a rate that is input by the user as the user is injecting.

The apparatuses described herein may provide the injection energy duringthe injection. These apparatuses may be used for more than 15 (more than20, more than 25, etc.) separate injections, and may include arefillable reservoir of between 30 cc to 60 cc (or more) capacity.

One particular advantage of these apparatuses is the ability of thedevice to both aspirate and to inject (in addition to filling). Forexample, a user (e.g., a doctor, surgeon, etc.) may aspirate through thesame needle from which injections are performed. This may allow the userto confirm the absence/presence of any arterial inflow.

These apparatuses may inject materials at an injection rate that isgreater than 0.25 cc/sec (e.g., 9.5 cc/sec, 0.75 cc/sec, 1 cc/sec, 1.25cc/sec, etc.). The injection rate may be substantially constant. Thisinjection rate may be significantly faster than manual injection (whichmay be less than 0.2 cc/sec and may require significant manual force).The apparatus may use any appropriate gauge needle, such as between 20G-32 G (e.g., 20-22 G needle, 30-32 G needle, etc.), and any appropriatelength of needle (such as between ½ inch to 3 inches, e.g., 1 inch, 1.5inch, 2 inches, etc.).

As used herein a viscous material that may be injected using theapparatuses described herein may have a viscosity of between about 10mPa*s and about 5000 mPa*s (at about 20 degrees C.). Thus, as will bedescribed in greater detail here, these apparatuses may be used for aviscous fluid having a viscosity of less than about 5000 mPa*s (e.g.,less than about 4000 mPa*s, less than about 3000 mPa*s, less than about2000 mPa*s, less than about 1000 mPa*s, less than about 500 mPa*s, lessthan about 300 mPa*s, less than about 200 mPa*s, less than about 100mPa*s, etc. at about 20 degrees C.).

In some examples, the apparatuses (e.g., systems, devices, kits andassemblies) and methods are described herein for delivering fluid to apatient, and particularly for delivering one or more doses of a viscousfluid using an apparatus that is configured to automatically andselectively deliver a predetermined dose at a high pressure. In someexamples the material delivered may be highly viscus. These apparatusesmay store multiple doses of the viscous material and are configured toprovide sufficiently high fluid pressure to deliver the multiple dosesof the viscous fluid, e.g., at set and/or selectable volumes, to thepatient in ways that may be fast, easy, and safe for both the patientreceiving the fluid and the operator delivering the fluid.

The apparatuses and methods described herein may be especially usefulfor delivering (e.g., topically or by injecting) viscous material into apatient's tissue. A viscous fluid may, for example, have viscosity ofgreater than 1×10⁻⁴ Pa*S, greater than 5×10⁻⁴ Pa*S, greater than 1×10⁻³Pa*S, greater than 5×10⁻³ Pa*S, or greater than 1×10⁻² Pa*S. Theapparatuses and methods described herein may be especially useful fordelivering (e.g., topically or by injecting) a relatively large quantityof fluid to a patient. In some examples, a fluid of interest may beviscous and diluted prior to injection to reduce its viscosity,resulting in a large amount of diluted fluid to be delivered. Thedevices described herein, which may be automatic and/or continuousfilling, may allow effective and safe injection of a viscous fluidand/or a relative large quantity of any fluid. In some particularexamples, the apparatuses may be configured to provide sufficiently highfluid pressure to inject the viscous fluid into a plurality of tissues,some or all of which may be highly resistant to injection. For example,the apparatuses may be useful for injecting a fluid (medicament) intotissues of a joint, such as periosteum, (a dense layer of vascularconnective tissue enveloping a bone), ligaments, tendons, and otherjoint tissues. The apparatuses and methods described herein may beespecially useful for delivering (topically or by injecting) a viscousfluid to a patient.

The viscosity of a fluid is related to its internal resistance to flow.Viscosity can be defined in two ways: “kinematic viscosity” or “absoluteviscosity.” Kinematic viscosity is a measure of the resistive flow of afluid under an applied force. The SI unit of kinematic viscosity ismm²/sec, which is 1 centistoke (cSt). Absolute viscosity, sometimescalled dynamic or simple viscosity, is the product of kinematicviscosity and fluid density. The SI unit of absolute viscosity is themillipascal-second (mPa-sec) or centipoise (cP), where 1 cP=1 mPa-sec.

The apparatuses described herein may generally be configured forcontinuous delivery of a material (e.g., a viscus material) into apatient, as described below. In some examples the material may beintermittently delivered, e.g., by pulsatile injection.

These apparatuses, which may be referred to herein a injectors, injectordevices, devices for automatic expulsion of a fluid, or the like, aretypically hand-held devices that may include a trigger or other controlthat may be actuated by the user to deliver a flow of material (viscusmaterial) a constant or variable flow rate. The flow rate may be set bythe user either before or during operation and may be adjustable. Insome examples the flow rate is constant. In some examples the flow rateis pulsatile.

Any of these apparatuses may be configured as automatic orsemi-automatic. For example, these apparatuses may include a drive motorthat is generally located on the hand-held device. In some examples, thedrive motor may be positioned at the proximal end of the hand-helddevice, e.g., near or at the upper end of the handle, so that it doesnot interface with the injection site. These devices may generallyinclude a needle (hollow sharp distal end) extending from the distal endof the device. The device may include a plurality of valves to allow thecontrol of flow from multiple sources, including multiple storagessources, such as multiple chambers and/or multiple removable bodies(e.g., in some examples syringe bodies). In some examples the pluralityof valves may be held within and/or formed integrally as part of a fluidvalve body, such as a fluid valve body assembly. The fluid valve bodymay be configured for injection molding processing and assembly. Any ofthese apparatuses may also include a controller, such as an electronicor electronics controller, which may be held within a housing in/on thedevice. The controller may control and/or coordinate operation of theapparatus as will be described in greater detail below.

In some examples the apparatus may include a control, such as a switch,selector, dial, valve, etc. configured as an injection selection switch.This control may have multiple settings that may control operation ofthe apparatus, including the selection of the amount of material to beinjected per actuation of the device (e.g., by pulling or holding thetrigger). For example, the switch may include settings for two or moreof: continuous, 1 cc, 2 cc, 4 cc, 10 cc, etc., to control the device todeliver the selected amount per trigger pull. In general, the selectionmay be controlled based on the volume to be delivered. Alternatively oradditionally, the apparatus may be configured to control deliverypressure (e.g., selecting among multiple delivery pressures). In someexamples the apparatus may be calibrated to deliver a predeterminedvolume based on a selected delivery pressure, or vice versa.

Any of the apparatuses described herein may also or alternativelyinclude one or more indicators on the body of the apparatus forindication the status of the apparatus, including the operational statusand/or the amount of material delivered, to be delivered and/orremaining the body of the apparatus. For example, in some examples theapparatus includes one or more light emitting diodes (LEDs) that areconfigured to indicate injection status (ready to inject,injecting/system OK, over pressure/fault/motor stall fault, etc.) Thesedifferent states may be indicated by color and/or position (e.g.,yellow, green, red, etc.). To transition between operational states, theapparatus may be configured so that the user operates a control (such asthe trigger), e.g., by releasing and/or sequentially releasing andengaging the trigger, etc. This may be indicated by the one or moreindicators.

In some examples, the apparatus may be configured so that the user mayapply a selectable amount of pressure to the grip and/or control (e.g.,trigger) in order to control operation of the device, including controloperation of the speed/rate of injection, the pressure, etc. Forexample, in some examples the apparatus may include one or more forcesensitive resistors (FSRs) embedded in the handle grip. The selector maysense an amount of force (grip strength) on the handle or a region ofthe handle and may adjust the sleep of the injection. For example, ifthe injector is in a continuous position then squeezing the handle maybe detected by the force sensor(s) and may adjust the speed ofinjection. The force sensor may be coupled to the controller (e.g., amicro-controller) that may then adjust the operation of the apparatus.

FIGS. 1A-1C show different views of one example of an injection device 4for delivering a fluid (e.g., a viscus fluid) to a patient. FIG. 1Ashows a side perspective view of the device 4. The device 4 has ahousing 8, a body region 10, and a head region 12. The body region 10includes a storage chamber 20 for storing a fluid for delivery and afirst grip 14. A storage chamber connector 32 fluidically connects thestorage chamber 20 to a fluid transfer manifold 44 (shown in FIG. 2A) inthe head region 12. The first grip 14 can be sized and shaped to begripped by a user's hand. The first grip 14 includes a trigger 22configured to control fluid delivery. The head region 12 also includes adelivery connector 36 configured to connect with and pass fluid from thefluid transfer manifold 44 in the head region 12 to a fluid deliveryelement, such as a needle (not shown in this view), for delivery to apatient. The delivery connector 36 may be a first fitting configured tomate with a second fitting, such as a sharp (needle). The deliveryconnection 36 and the connection on the second fitting may be a sliptip, such as a Luer lock or Luer slip fitting. FIG. 1A also shows headregion 12 with a thumbscrew 26 and a second grip 16. FIG. 1B shows afront perspective view of the injection device shown in FIG. 1A. Thefirst grip 14 and/or second grip 16 may be ergonomically sized andshaped, such as being curved for easier gripping or having finger and/orindents that may make for more secure gripping. The first grip 14 and/orsecond grip 16 may be made from plastic, and may be coated or coveredfor usability and comfort such as with a tacky or cushioned material.The device may be readily sterilizeable.

FIG. 1B shows the trigger 22 for controlling fluid movement and theswitch 24 for turning the device on and off.

In addition to the delivery connector 36, FIG. 1B shows the headportions of screws 21A, 21B, 21C, and 21D on the distal end of thedevice. In some examples, the screws corresponding to these 21A, 21B,21C, 21D screw into channels in tubing or piping in the fluid transfermanifold 44, sealing the manifold from leakage. FIG. 1C shows a backperspective view of the injection device shown in FIG. 1A, looking downthe barrel 30 of the storage chamber 20 from a proximal to distaldirection. FIG. 1D shows a diagram of a knee joint and sites in andaround the knee joint where an injection of a fluid (e.g., ananti-inflammatory drug or pain medication) may be made during a kneejoint procedure using the devices or methods described herein. Aplurality of injections may be made to deliver the fluid at asufficiently high concentration to a sufficient number of tissues. Theinjections may be made by the injection device described herein byeither moving a needle to a variety of different positions within thebody, including to positions that are at different depths in the tissue(deeper or shallower in the tissue) or at separate locations (byremoving the needle out of the tissue and from one site and reinsertingit into a second site).

For example, by way of example only, a knee may be injected as shown inFIG. 1D. In this example, 8-10 sticks may be made, 101, in the medialposterior capsule, 8-10 sticks in the lateral posterior capsule 102, andin the femur-medial and lateral periosteum, posterior periosteum,suprapatellar/quadriceps tendon as shown 103. Five sticks may be made inthe tibia fat pad 104, and 15-20 sticks may be made in thecircumferential periosteum 105. Ten sticks are shown made in the midlinequadriceps tendon 106 and ten sticks in the retinaculum, medial gutter,femoral to tibia 106, ten sticks in the lateral gutter, femoral totibial and ten sticks subcutaneously for closure. The injections may bemade using a continuous injection, or by selecting predetermined volumesor pressures. Each site may be, for example, injected with from 0.5 mlsto 3 mls each.

FIGS. 2A-2B show partially transparent views of another example of adevice 4 similar to that shown in FIG. 1A. FIG. 2A shows a partiallytransparent side view and FIG. 2B shows a partial side cross-sectionalview. FIG. 2A shows the head region 12 as partially transparent tobetter illustrate the fluid transfer manifold 44 inside. FIG. 2B showsthe second grip 16 as partially transparent to better show the motor 116inside. The motor 116 is connected to the drive system and moves thetiming belt 118. The motor 116 includes a sensor 100. The device 4 alsoincludes a controller. The controller reads information from the sensor100. The device 4 also includes a hall limit switch to find home onreset. The fluid transfer manifold 44 may be made from piping or tubing,may be assembled from separate pipes or tubing or may be made byadditive manufacturing (e.g., 3D printing) as a single or severalpieces. The sensor 100 may be an encoder configured to convertmechanical information (e.g., position of the motor shaft) into a usableelectrical signal (that can be used by the micro controller to change asignal or data into a code. The encoder may track the turning of themotor shaft and detect movement direction and/or movement speed. Theencoder could be a mechanical encoder (an electro-mechanical encoder), amagnetic encoder, an optical recorder, or a resistive encoder. Theencoder may be a quadrature encoder configured to detect which way themotor shaft is turning. The encoder may be a rotary encoder and mayconvert the angular position of the motor shaft into a digital coderotation of the motor shaft. Although shown in the second grip 16 thesensor 100 could also be located elsewhere in the device.

In general, any of the apparatuses described herein may include two ormore (e.g., a plurality) of sub-chambers, such as sub-cylinders, assecondary delivery chambers that mechanically multiply for force appliedby the apparatus when delivering material from the storage chamber outof the needle. The apparatus may reciprocally pump, via one or morepistons, fluid from the storage chamber (which may be swapped out and/orrefilled), into the smaller-volume secondary delivery chambers, and themreciprocally pumped out of the smaller-volume secondary deliverychambers and out of the distal end tip of the device, as described ingreater detail below. In some examples, the ratio of the size anddimensions of the secondary delivery chambers may be calibrated so thatthe force required to pump from the smaller secondary chamber in orderto achieve the higher pressure is less than a threshold.

FIG. 3A-FIG. 3J show different views of the drive system of the device 4configured to provide delivery of a fluid (e.g., continuous of ahigh-pressure fluid). In this example, the device 4 provides acontinuous flow of high-pressure fluid for delivery by alternatelypassing fluid through one of two narrow delivery chambers before fluiddelivery. FIG. 3A shows a partially cut-away top view of the device 4shown in FIG. 1A. FIG. 3B shows a similar view as FIG. 3A with thestorage chamber 20 and other components removed. FIG. 3C shows a similarview with the battery 104 and other components removed. FIG. 3D shows asimilar view with the housing and some of the other components removed.FIG. 3E shows a side view similar to the view in FIG. 3D with the firstdelivery chamber removed. FIG. 3A shows the timing belt 118 configuredto rotate about the timing belt pulley 120 as the timing belt pulley 120rotates. The timing belt pulley 120 is operationally connected to thefirst carriage 68 and the second carriage 84 (better seen in FIG. 3B andFIG. 3C). FIG. 3B and FIG. 3C show an example of the device 4 configuredto use narrow delivery chambers, such as small, narrow syringes, as thefirst and second delivery chambers 58, 78 to provide high pressure outof the device 4 (e.g. for delivery to a patient). The first and seconddelivery chambers 58, 78 alternately deliver their fluid payloads to thedelivery connector 36 and its connected delivery element 38 (fordelivering to the patient; not shown in this view) for continuous fluiddelivery from the device 4. In particular, while the first deliverychamber 58 is emptying its payload to the delivery connector 36 and itsconnected delivery element 38, the second delivery chamber 78 is fillingwith fluid from the storage chamber 20. FIG. 3B and FIG. 3C show firstdelivery chamber 58 with a corresponding first plunger 60 and seconddelivery chamber 78 with a corresponding second plunger 80. The firstdelivery chamber 58 is configured to receive the first plunger 60 andthe second delivery chamber 78 is configured to receive the secondplunger 80. The first plunger 60 is configured to slide along the insideof the barrel of the first delivery chamber 58 and the second plunger 80is configured to slide along the inside of the second delivery chamber78. FIG. 3B and FIG. 3C also show the timing belt 118 operativelyconnected to the first carriage 68 and the first carriage 68 operativelyconnected to the first plunger 60 so that when the timing belt 118 moves(rotates) clockwise, the first carriage 68 translates from a proximallocation to a distal location. The first carriage carries the firstplunger 60 and translates the first plunger 60 from a proximal locationto a distal location, moving the first plunger 60 through the firstdelivery chamber 58, and expelling fluid out of the distal end of thefirst delivery chamber 58. In this example, the first and seconddelivery chambers 58, 78 are syringes that alternately empty and fill,although configurations that do not involve a syringe are alsocontemplated (see below). A delivery chamber or a storage chamber (e.g.,a syringe) may be made from glass, metal, or plastic. In some particularexamples, a syringe body and plunger made from polypropylene, a plungeror part of a plunger made from polyethylene. A delivery chamber (e.g., asyringe) may be a commercially available component (e.g., syringe, suchas made by BD, Becton, Dickinson and Company, Franklin Lakes, N.J.) ormay be custom made. Delivery chambers may be configured to hold from 0.1to 10 mls (10 cc). Delivery chambers may be 0.1 ml syringes, 1 mlsyringes, 2 ml syringes, 3 ml syringes, 4 ml syringes, 5 ml syringes, 10ml syringes, (or anything in between these sizes). Smaller syringes(e.g., those with a narrower bore) generally deliver higher pressuresthan do syringes with a larger bore, and so a narrow syringe with alonger barrel may be used to obtain a combination of high pressure andsufficient volume. An inner diameter of a first or second deliverychamber 58, 78 (syringe) may be less than 12.1 mm (e.g., a 3 ml orsmaller syringe), less than 8.9 mm (e.g., a 1 ml or smaller syringe),less than 6.5 mm (e.g., 0.5 ml or smaller), or less than 4.9 mm. Thedelivery chamber size may be chosen so that it generates sufficientpressure for desired expulsion from the device 4 or injection into atissue, especially a resistant tissue. A device with a 1 ml deliverychamber syringe may be chosen for injecting tissues with greaterresistance, such as knee joint or hip joint tissues. In some examples,the delivery chamber(s) (and storage chamber) are part of a device. Inother examples, the device may include some subsystems or partsdescribed herein and exclude others. For example, some examples ofdevices described herein may include the delivery chamber(s) and/orstorage chamber while in other examples, the device does not include thedelivery chamber(s) and/or storage chamber. A device may be configuredwith one or more holder components configured to accept and/or attachsome subsystems or parts, such as accepting and attaching a deliverychamber(s) and/or a storage chamber through snap fastener plastic beamsnap-in part(s) or plastic cylinder snap-in part(s) on the device. Theholder components may be configured to accept and hold an off-the-shelfor custom made part, such as an off-the-shelf or custom made syringe orother delivery chamber. Holder components be configured for acceptingand/or holding various parts (e.g., delivery syringe barrel, deliverysyringe plunger, storage syringe barrel, storage syringe plunger,battery). A syringe or delivery chamber may connect to other parts ofthe fluid transfer system of the device through a Luer lock or otherconnector.

FIG. 3B and FIG. 3C also show the timing belt 118 operatively connectedto the first carriage 68 and the first carriage 88 operatively connectedto the second plunger 80 so that when the timing belt 118 moves(rotates) clockwise (e.g., around a shaft of the pulley mount 122), thesecond carriage 88 translates from a more distal location to a moreproximal location (e.g., in the opposite direction that the firstcarriage 58 translates). The second carriage 88 then translates thesecond plunger 80 from a more distal location to a more proximallocation, pulling the second plunger 80 through the second deliverychamber 78, and drawing fluid from the storage chamber (e.g., reservoir)20 through the second chamber delivery port and into the distal end ofthe second delivery chamber 78. As explained in more detail below, whenthe timing belt pulley 120 changes the direction of rotation fromclockwise to counterclockwise, the situation is reversed and the seconddelivery chamber 78 expels fluid while the first delivery chamber 58fills with fluid. FIG. 3D shows a partial perspective view of theproximal end of the device 4 shown in FIG. 1A. FIG. 3D also shows inmore detail the first carriage 68 operatively connected to the timingbelt 118 and the head 74 of the first plunger 60 received (attached) toa mating slot 76 in the first carriage 68 so that movement of the timingbelt 118 translates both the first carriage 68 and the first plunger 60.Similarly, FIG. 3D also shows the second carriage 88 operativelyconnected to the timing belt 118 and the head 94 of the second plunger80 received (attached) to a mating slot 96 to the second carriage 88 sothat movement of the timing belt 118 translates both the second carriage88 and the second plunger 80. In this example, the proximal end of thefirst carriage 68 and second carriage 88 abut the pulley mount 122,stopping proximal movement of the first carriage 68 and second carriage88 and preventing the first plunger 60 and the second plunger 80 frommoving out of their respective first and second delivery chambers 58,78, although other methods of stopping proximal translation of the firstplunger 60 and the second plunger 80 are also contemplated.

FIG. 3G shows a proximal partially perspective view of the device 4 withplunger 52 of the storage chamber (e.g., reservoir) 20 and othercomponents removed. FIG. 3F shows the first delivery chamber 58 and thefirst guide 72 as well as the second delivery chamber 78 and secondguide 92. FIG. 3E also shows the timing belt 118 extending into theplane.

FIG. 3H shows a top perspective view of a first carriage 68 or secondcarriage 88. The first carriage 68 and second carriage 88 are shown asthe identical in this example, although they do not need to beidentical. FIG. 3I shows a side perspective view of the carriage shownin FIG. 3H with the carriage rotated so the view is proximal. FIG. 3Hand FIG. 3I show the first carriage channel 70 (or second carriagechannel 90) for receiving the first shaft guide 72 (or second shaftguide 92) as shown in FIG. 3J. The first guide shaft 72 and second guideshaft 92 are shown as extending longitudinally and substantiallystraight in this example, although other examples are contemplated. Thefirst guide shaft 72 and second guide shaft 92 fit inside the firstcarriage channel 70 and second carriage channel 90 and are togetherconfigured so that the first guide shaft 72 and second guide shaft 92fit inside the first carriage channel 70 and second carriage channel 90move relative to one another. An outer cross-sectional shape of theguide shaft and an inner cross-sectional shape of the carriage channelmay be circular, oval, ovoid, and triangular. FIG. 3K shows a bottomside perspective view of the device 4 with the housing and some othercomponents removed. FIG. 3K shows part of the device transmission. FIG.3K shows the motor 116 and the battery 104 for providing power to themotor 116. FIG. 3K also shows the second pulley 114 attached to themotor 116. The distal portion of the timing belt 118 is tensioned aroundthe second pulley 114. Rotation of the motor 116 in one direction drivesthe pulley to rotate and activates the transmission, moving the firstplunger 60 and the second plunger 80, filling the first delivery chamber58 with fluid from the storage chamber 20, while expelling fluid fromthe second delivery chamber 78. Reversing the direction of rotation ofsecond pulley 114 reverses the actions, expelling fluid from the firstdelivery chamber 58 while filling the second delivery chamber 78 withfluid from the storage chamber 20.

FIG. 4A-FIG. 4G show parts of the fluid transfer system of the device 4.FIG. 4A shows a side perspective view of the head region 12, whichcontains much of the fluid transfer system. FIG. 4B a shows partial sideperspective views of part of the fluid transfer system and FIG. 4C showsa closer up view of the head region 12 with the head region housingtransparent. FIG. 4B-FIG. 4E, show a first valve 140, a second valve142, a third valve 144, and a fourth valve 146 in the fluid transfermanifold 44. In some examples another valve (not visible here) may beincluded for aspiration, as described below. These valves may be, e.g.,PTFE ball valves. Thus, in some examples, five conical seats and balls(valves) may be present in the hydraulic head.

The first valve 140 is in the fluidic pathway between the storagechamber 20 and both the first delivery chamber 58 and the seconddelivery chamber 78. The second valve 142 is in the fluidic pathwaybetween the first delivery chamber 58 and the delivery port 42. Thethird valve 144 is in the fluidic pathway between the second deliverychamber 78 and the delivery port 42. While the first delivery chamber 58is expelling its fluid payload to the delivery port 42 (and the patientthrough a delivery element), the second delivery chamber 78 is fillingwith fluid from the storage chamber 20; the first valve 140 is open, andfluid flows from first delivery chamber 58 to the delivery port 42. Asfluid is pulled into the second delivery chamber 78 from the storagechamber 20 by the pull from the second plunger 80 being withdrawn (bythe rotating transmission system), the second valve 142 closes. Thefirst valve 140, the second valve 142, the third valve 144, and thefourth valve 146 may be, for example, one way check valves or otherautomatic valves. In preparation for using a device 4, the device may beprimed. If a device does not already have delivery chambers and/orstorage chambers, delivery chambers and/or storage chambers may beloaded or attached to the device. The plunger 52 of the storage chamber20 may be pushed to load fluid into the first delivery chamber 58 and/orsecond delivery chamber 78 to prime the device. Some examples includethe step of priming (e.g., manually priming or with a trigger) the firstdelivery chamber 58 or priming (manually priming) the second deliverychamber 78. Once primed, atmospheric pressure on the storage chamber 20(e.g., syringe or tubing) fills the first delivery chamber 58 and thesecond delivery chamber 78 on their intake strokes as the transmissionrotates. Pressures from about 5 psi to about 400 psi (e.g., between 5and 300 psi, between 5 and 250 psi, between 5 and 225 psi, between 5 and200 psi, etc.) may be generated in the device 4. In some examples, theautomatic expulsion device may be configured to deliver fluid with afluid pressure of at least 5 psi, at least 10 psi, at least 50 psi, atleast 100 psi, or at least 150 psi, and/or less than 500 psi, less than400 psi, less than 300 psi, less than 250 psi, less than 200 psi, lessthan 150 psi, less than 100 psi or anything between these values. Thepressure may be determined anywhere in the device. In some examples, thepressure can be determined in the first delivery chamber 58, the seconddelivery chamber 78 (if the device has one), or at the tip of a combinedstorage/delivery chamber (see below). In some particular examples,pressure may be determined at the tip of any of these chambers. Any orall of the first delivery chamber 58, the second delivery chamber 78,and/or the combined storage/delivery chamber may include a pressuresensor for detecting the pressure. The pressure sensor may have afeedback loop to the motor/microcircuit. A delivery element 38 may be ahollow sharp 34 such as a needle, such as from a 20 gauge needle to a 32gauge needle (e.g., a 21 gauge needle, a 22 gauge needle, a 23 gaugeneedle, a 25 gauge needle, a 27 gauge needle, a 30 gauge needle, 31gauge needle, or a 32 gauge needle). In some examples, a larger (lowergauge) needle may be useful for injection into a joint. In someexamples, a smaller (higher gauge) needle may be useful for facialinjection. Pressure between 5 psi and 500 psi (e.g., between 5 and 400,between 5 and 300, between 5 and 250, between 5 and 200, etc.) may begenerated with ˜3-5 lbf delivered from the motor (e.g., a geared DCmotor) and timing belt. The device may be configured to deliver at least30 mls fluid, at least 45 mls fluid, at least 60 mls fluid, at least 100mls, or at least 200 mls fluid or up to 200 mls, up to 100 mls, up to 60mls, up to 45 ml, up to 30 mls at a given pressure. For any of theexamples described herein, the device may be configured to deliver fluid(e.g., through the fluid transfer manifold) at a rate of 0.5 cc/secondto 8 cc per second, such as from 1 cc/second to 5 cc/second for a givenpressure and volume. A timing belt may be low cost, symmetric, andpackage well.

FIG. 4G also shows the fluid transfer manifold 44. The fluid transfermanifold includes a first fluidic pathway connecting the storage chamber20 to the first delivery chamber 58, a second fluidic pathway connectingthe storage chamber 20 to the second delivery chamber pathway 78, athird fluidic pathway connecting the first delivery chamber 58 to thedelivery port 42 (and hollow sharp 34 or other delivery element), and afourth fluidic pathway connecting the second delivery chamber 78 to thedelivery port 42 (and hollow sharp 34 or other delivery element). Asexplained in more detail below, the fluid transfer manifold 44 may alsoinclude a fifth fluidic pathway connecting the delivery port 42 (andhollow sharp 34 or other delivery element) to the storage chamber 20.The fluid delivery manifold 44 may be connected to the first deliverychamber 58, the second delivery chamber 78, the storage chamber 20, andthe delivery element 38 via Luer lock fittings and the fluid deliverymanifold 44 may have three input Luer lock fittings and one output Luerlock fitting.

FIG. 4A-FIG. 4D also show thumb screw 26. Another valve may be in thefluid pathway connecting the storage chamber 20 with the delivery port42 (and a hollow sharp needle that may be attached to the delivery port42 and inserted into a patient, not shown in these views) which may bereferred to herein as an aspiration pathway. The aspiration pathway may,in some examples, aspirate material, such as a tissue sample, from apatient. The thumb screw 124 can control the operation of the aspirationpathway. The thumb screw 124 controls the operation of the additional(e.g., aspiration) valve. When the thumb screw 124 is rotated in a firstdirection (e.g., clockwise or counterclockwise), the thumb screw closesthe additional valve and fluid cannot flow from the delivery port 42 (orhollow sharp 34 inserted into a patient) to the storage chamber 20. Thismay close the aspiration pathway. When the thumb screw 124 is rotated ina second direction (e.g. counterclockwise or clockwise, respectively),it may open the aspiration valve and a fluid pathway may be openedbetween the delivery port 42 (and hollow sharp tip/needle) to thestorage chamber 20 (e.g., opened from the delivery port to the storagechamber 20). The aspiration pathway in this configuration is open.Withdrawing the storage chamber plunger 52 in the storage chamber 20 maycreate a pull or vacuum, and when the sharp tip of the device (e.g.,needle) has been inserted into a patient, can draw a sample from thepatient in through the hollow sharp needle and into the storage chamber20. In some examples, a method of operating the device may includedetermining if the aspirated sample is a blood sample (e.g., from ablood vessel). Determining if the aspirated sample is a blood sample mayinclude the step of inspecting the device (e.g., the storage chamber)for the presence of blood, indicative that the tip of the sharp needle(“sharp”) is in a blood vessel. (If fluid is injected from the deviceinto the site, it will be injected into a blood vessel and the fluidwill carried away from the local site, rather than having a localeffect. Determining may include, for example, visually inspecting thestorage chamber by the user to look for the presence of red color in thestorage chamber, although other methods (such as use of a light based orsensor) may also or instead be performed. In some examples, it isundesirable to inject the fluid from the device into a blood vessel, andso the user of the device may move the device (e.g., the hollow sharpend of the device) from a first region of the body that is in a bloodvessel to a second region of the body to find a body region that is nota blood vessel. Placing the hollow sharp needle (or tip 34) into asecond region may include the steps of inserting the hollow sharpneedle/tip further into the patient to a second region, partiallywithdrawing the hollow sharp from the first region of the patient to asecond region, or fully withdrawing the hollow sharp needle from thepatient, and reinserting the hollow sharp needle into the patient into asecond region. The aspiration and visualization process including movingthe device may be repeated until it is determined (e.g., automaticallyand/or manually) that a significant amount of blood is not beingwithdrawn, indicative that the tip is not located in a blood vessel. Itis noted that the distal end of the hollow sharp tip may be placed in atissue, such as certain dense tissues, and may not aspirate any sample.The absence of a sample upon aspiration may be taken to indicate thatthe distal tip of the needle is not in a blood vessel. Thus, someexamples may include the steps of inserting a hollow sharp tip (needle)into a location in a patient; taking a tissue sample from a patientthrough a hollow sharp needle; determining if the tissue sample is ablood sample; and removing the hollow sharp needle from the locationwithout expelling fluid from the device if the tissue sample is a bloodsample. Some examples may include withdrawing a tissue sample into astorage chamber and/or assaying the sample to detect blood. Someexamples may include repeating these steps. In some examples, the device4 may have a translucent part, a transparent part, and/or a clear part(e.g., window) through which the tissue sample (e.g., blood sample) maybe visualized by the user. In some examples, the storage chamber barrelmay be translucent, transparent or clear of may have a translucent part,a transparent part, and/or a clear part (e.g., a window). The window maybe useful for determining if an aspiration sample is a blood sample. Insome examples, the device may be configured so that the plunger 52 ofthe storage chamber 20 is readily accessible to a device user, and auser may withdraw the plunger 52 a sufficient distance to remove atissue sample.

Peristaltic Fluid Delivery Systems

Also described herein are peristaltic systems for an injection devicefor fluid delivery using pressurized fluid to move the fluid through thedevice. Thus, any of these apparatuses may be configured to operate viaperistaltic fluid delivery.

FIG. 7A-FIG. 7C show an example of part of a peristaltic fluid deliverydevice 174 for delivering a fluid to a patient. FIG. 7A and FIG. 7B showlongitudinal cross-sectional views of parts of the peristaltic fluiddelivery device 174. FIG. 7C shows a cross-sectional view of part of thedevice shown in FIG. 7B. This peristaltic fluid delivery device 174 canbe similar to the device 4 described above (e.g., FIG. 1A), and includethe same or similar systems and components (e.g., fluid transfermanifold, valves, reservoir, drive system, sensors) and have the same orsimilar specifications, except that instead of delivery chambers and/orstorage chambers being syringes (barrels with plungers) the peristalticsystem utilizes fluid filled tubes as delivery chambers for fluid and acompression part to expel the fluid (e.g., instead of a syringeplunger). In some examples, the storage chamber may be a molded part andmay be directly connected or directly molded with the fluid transfermanifold. Such directly molding could simplify the device and reducecost, especially in a disposable or partially disposable device in whichthe device or parts of the device are not reusable. In some examples,the storage chamber may be located in the handle. FIG. 7A shows theperistaltic fluid delivery device 174 has an elongate first peristalticdelivery chamber 176 having a proximal end 180 and a distal end 182 anda length between. The first peristaltic delivery chamber 176 may be atubing. The tubing may made from polyether ether ketone (PEEK),polytetrafluoroethylene (PTFE), or another thermoplastic or semi-rigidprecision material. The tubing may be configured so it does notdiametrically expand under the pressures used (e.g., 3 psi-500 psi, 3psi-400 psi, 3 psi-300 psi, 3 psi-200 psi, etc.). At the distal end 182of the first peristaltic delivery chamber 174 is a distal connector 184configured to connect with the fluid transfer manifold 44 throughmanifold connector 186, although in some examples the first peristalticdelivery chamber 176 may be directly attached to the manifold connector186. The distal connector 184 and/or the manifold connector 186 may be aLuer fitting (or part of a Luer fitting) or another suitable fluidfitting, such as a National Pipe Taper (NPT) fitting. The firstperistaltic delivery chamber 176 may be connected to the distalconnector 184 or the manifold connector 186 by heat shrinking the distalend 182 of the tubing onto the connector. The proximal end 180 may besealed shut such as by pinching closed and retaining. In some examples,the proximal end 180 is retained in the pulley mount (e.g., pulley mount122). Similar to as described elsewhere herein, the tubing has a sizeand diameter to provide a sufficient volume of fluid at a sufficientpressure for delivery to the patient. In some examples, the tubing maybe from 1 cm to 25 cm in length, such as from 2 cm to 20 cm or 5 cm to15 cm. The tubing may be configured to hold at least 0.1 mls, at least0.5 mls, at least 1.0 ml, at least 2.0 mls, at least 3 mls, at least 4mls, or at least 5 mls. The tubing may be configured to hold up to 10mls and to hold any amount between these values, such as to hold from0.1 mls to 10 mls (10 cc), from 0.5 mls to 5 mls, from 0.5 mls to 3 mls.An inner diameter of the tubing may be less than 20 mm, less than 15 mm,less than 10 mm, or less than 5 mm or larger than 1 mm, larger than 5mm, larger than 10 mm, larger than 15 mm or anything in between thesesizes. The tubing may be from 1 cm to 25 cm in length, such as from 2 cmto 20 cm or 5 cm to 15 cm. In a particular example, the tubing is about10 cm in length. Although described with reference to the firstperistaltic delivery chamber 176 similar to as described elsewhereherein for the device 4, the peristaltic fluid delivery device 174 canhave a second peristaltic delivery chamber which is the same or similarto the first peristaltic delivery chamber 176. In some examples, thestorage chamber may be a syringe as described elsewhere herein, thoughin other examples, it may include tubing. A storage chamber (e.g., astorage chamber 20) may include a helper spring to aid in moving a shaftor carriage for filling a first or second delivery chamber. Furthermorethe FIG. 7B shows the first peristaltic delivery chamber 176 shown inFIG. 7A with a first delivery tube carriage 190 for controlling fluidflow in and out of the first peristaltic delivery chamber 176. Thecarriage has a first compression roller 192 and a second compressionroller 194 (e.g., a fixed idler roller), which may have a proximalcompression roller 196 and a distal compression roller 198. The firstcompression roller 192 may be a spring loaded compression roller and mayinclude a roller spring 200. FIG. 7B and FIG. 7C also show a shaft 202.The first delivery tube carriage 190 can be connected to the timingbelt. The first delivery tube carriage 190 may be configured to move orroll along the shaft 202 from a proximal location to a distal locationand from a distal to a proximal location when the timing belt rotates(e.g., oscillates or alternately rotates clockwise andcounterclockwise). As the first delivery tube carriage 190 moves orrolls, it successively compresses the tube of the first peristalticdelivery chamber 176 against the shaft 202. The first delivery tubecarriage 190 increases pressure inside the tubing, expelling fluid fromthe tube of the first peristaltic delivery chamber 176 to the deliveryport 42 when the first delivery tube carriage 190 is moving distally.The first delivery tube carriage 190 decreases pressure inside thetubing when the first delivery tube carriage 190 is moving proximally,drawing fluid into the tube of the first peristaltic delivery chamber176 from the storage chamber. These steps may be repeated to repeatedlydispel fluid from one or the other of the first or second deliverychambers to the patient (in the distal pointing direction arrow 204)while filling the other of the first or second delivery chambers (shownby the proximal pointing direction of the arrow 204). In use and as seenin FIG. 7C, the first compression roller 192 and the second compressionroller 194 may compress and compress the tubing of the first peristalticdelivery chamber 176. The first compression roller 192 has a rollerspring 200 and the roller spring 200 may compress the tube of the firstperistaltic delivery chamber between first compression roller 192 andthe second compression roller 194 together as the first delivery tubecarriage 190 travels distally to expel the fluid or proximally to pullfluid into the tube of first peristaltic delivery chamber 176. Theproximal portion of the first peristaltic delivery chamber 176 (tubing)is a collapsed dead volume behind each injection stroke to distal endand when the first delivery tube carriage 190 moves proximally, thefirst peristaltic delivery chamber 176 (tubing) fills up underatmospheric pressure. Although the first compression roller 192 is shownas having a single roller and the second compression roller 194 is shownas having two rollers, any of the rollers could be or include oneroller, two rollers, three rollers, or more than three rollers. Theshaft 200 may be from 1 mm to 10 mm in diameter, such as from 3 mm to 6mm in diameter. In some examples, the shaft is about 4 mm in diameter.FIG. 8 shows peristaltic fluid delivery device 210. The device issimilar to as described above for peristaltic fluid delivery device 174.FIG. 9 shows another example of a portion of a peristaltic device.

FIG. 10A shows another peristaltic fluid delivery device 236 (e.g.,including a drive assembly for such a device). The device is similar toas described above for the peristaltic fluid delivery device 174 exceptthat in this example a lead screw (with a region of right hand threadsand a region of left hand threads) is used to simultaneouslymove/translate both the carriages. With the use of a worm gear, themotor is located proximally in the device. A proximally located motormay eliminate interference with a patient in soft tissue procedures. Aproximally located motor may also streamline the volume of the device,creating a more ergonomic device for some applications. FIG. 10A showsthe first peristaltic delivery chamber 176 (tubing) with a first leadscrew carriage 238 and second peristaltic delivery chamber 178 (tubing)with a second lead screw carriage 240. FIG. 10A also shows lead screwshaft 250 or worm screw with right hand threads 254 and left handthreads 256. The first lead screw carriage 238 is configured to matewith the left hand threads 256 and the second lead screw carriage 240 isconfigured to mate with the right hand threads 254. When the motor 116or worm gear turns the lead screw shaft 250 through hub 252, the leadscrew shaft simultaneously moves one of the carriages proximally,expelling its fluid contents and moves the other carriage distally,filling the tubing from the storage chamber (not shown in this view) asdescribed elsewhere herein. FIG. 10B shows a side view of the firstperistaltic delivery chamber 176 shown in FIG. 10A (and in FIG. 10C)with the roller. FIG. 11 shows another example of a portion of a driveassembly.

FIG. 12A-FIG. 12C show another example of a device, shown as manualdevice 310, which has a single chamber and maybe manually powered. FIG.12A shows the device 310 with a fluid delivery chamber 312 with asyringe barrel 318 configured to hold a fluid, a syringe plunger 320configured to slide within the syringe barrel 318, and teeth 322 of aratchet system on the underside of the syringe plunger 320. In thisexample, the teeth 322 run the length of the plunger, though otherconfigurations are possible. FIG. 12A also shows grip 314 with anaspiration control 326 and an expulsion control 328. Activating theaspiration control 326 engages the ratchet, moving the syringe plunger320 proximally to aspirate a sample (or determine a sample cannot beaspirated) and analyze as described elsewhere herein. Activating theexpulsion control 328 engages the ratchet, moving the plunger distallyto expel fluid through the delivery port 42 for delivery to a subject.

In FIG. 12B, syringe barrel 318 has been rotated 180° (as indicated bythe proximal arrow) to disengage the ratchet mechanism on the syringeplunger 320. Pulling back (proximally) on the syringe plunger 320 willfill the fluid delivery chamber 312 from a source 330 of fluid. FIG. 12Cshows pulling the handle and moving the handle from a first positionshown as handle 316 a to a second position shown as handle 316 b, movesthe ratchet a distance to expel 10 cc (10 mls) of fluid from the device310 to a patient. In this example, each “click” of the handle expels 1cc (1 ml) though other configurations are possible. However, therelationship between the distance the handle moves (and the number ofclicks), controls the amount of fluid expelled so that a controlled doseof a fluid is delivered. For delivery of an opioid or other controlledsubstance, controlling the dose delivered (or knowing how much isdelivered) may be important.

Any of the apparatuses described herein may be reusable or alternativelydisposable. In some examples these apparatuses may include a reusableframe that engages with one or more disposable syringes. For example,the example shown in FIGS. 12A-12B may be a semi-disposable unit and mayinclude a reusable frame with a disposable syringe. This example may bemanual or battery powered. For example, in some examples, the batteryand motor may fit into the handle. The motor may have a toothed gear(e.g., cogwheel) that would interact with the undersurface of theplunger of the syringe (which may also would have a row of teeth/cogs toengage therewith). In some examples, the plunger may or may not need tobe rotated to fill the contents of the syringe.

FIG. 13 show another example of a device, device 340, which has a singlechamber for fluid delivery similar to the device shown in FIG. 12A.However, device 340 has a pistol grip 346 with a motor 342 at the top,powered by a battery 104. The motor 342 is controlled by a microcircuitboard powered by the battery 104. device 340 has a fluid deliverychamber 312 with a syringe barrel 318 configured to hold a fluid, asyringe plunger 320 configured to slide within the syringe barrel 318,and teeth 322 of a ratchet system on the underside of the syringeplunger 320 similar to as shown in FIG. 12A. FIG. 13 also shows motor342 with mating element 344 configured to mate with teeth 322.Activating the aspiration control 326 rotates the motor in a firstdirection, engaging the mating element 344 and teeth 322, moving syringeplunger 320 proximally for aspirating a sample from a patient (ordetermining a sample is not aspirated). The sample can be obtained andanalyzed as described elsewhere herein. Activating the expulsion control328 rotates the motor 342 in a second direction (e.g., oppositedirection), engages the ratchet, moving the plunger 320 distally toexpel fluid through the delivery port 42 for delivery to a subject. Insome examples, the fluid delivery chamber 312 can be filled as describedabove for FIG. 12B by disengaging the ratchet and drawing the plunger320 proximally. In some examples, a sample can be aspirated by rotatingthe plunger 180° to disengage the teeth 322 from the motor 342, andusing manual pulling to aspirate fluid. FIG. 21 shows a flow chart ofthe method of delivering a fluid.

Any of the devices described herein may be configured to besterilizable, such as by an autoclave and so may include parts that areresistant to heat and/or pressure. Any of the devices described hereinmay be made to have components that integral, built-in, and disposableso that the whole device is disposable. Any of the devices describedherein may have parts that are readily separable such that part of adevice is disposable and part is reusable. For example, in someexamples, the grip (pistol grip), motor, microcircuit, and/or batterycould be reusable and the fluid transfer manifold and first and seconddelivery chambers are disposable. In some examples, the battery could bea rechargeable battery and the reusable part of the device may beconfigured so that the battery is available to be recharged.Furthermore, disposable parts may be simple and low cost in order tokeep manufacturing costs down. For example, a small timing belt may below cost, symmetric, and package well. In some examples, part of thedevice may be removable for separate disposal. For example, a device maybe configured to have a readily removable battery so that the batterycan be disposed of or recycled separately from the rest of the device.

Fluids

The devices described herein may be used to deliver various fluids, butmay be especially useful for delivery of a viscous fluid. Examples ofsome fluids that may be delivered include abobotulinumtoxinA, ananalgesic, articaine, Botox®, botulinum toxin, bupivacaine, calciumhydroxylapatite, collagen, a colloid, dermal filler, dexamethasone,dibucaine, Dysport®, an emulsion, etidocaine, Exparel®, fat, a gel,hyaluronic acid, lidocaine, a liposome encapsulated drug, mepivacaine,onabotulinumtoxinA, poly-L-lactic acid, polymethylmethacrylate (PMMA),prilocaine, procaine, ropivacaine, tetracaine including mixtures and/orsalts and/or derivatives thereof. In some particular examples, theautomatic expulsion device may be used to deliver a bupivacaine liposomeinjectable suspension (Exparel®). A fluid as used herein may include aliquid, a suspension. A fluid for delivery with the automatic expulsiondevice described herein may include particles (microparticles), such asparticles with a mean diameter of 0.5 μm to 100 μm, 5 μm to 75 μm, 10 μmto 60 μm, 15 μm to 75 μm, 20 μm to 50 μm.

Examples

FIG. 24 illustrates an example of a storage chamber (e.g., reservoir)and first and second delivery chambers (e.g., first and second pistonchambers) that may be used with various examples of the apparatusesdescribed herein. FIG. 17 shows an example in which the storage tank ofthe apparatus is a tank 2407 that is fluidically connected to a firstdelivery chamber 2201 and a second delivery chamber 2201′ via valvedconnections, as described and discussed herein. In this example, thetank may include an inlet 2203 in which fluid to be injected may beinput. The fluid may be pressurized. Thus in some examples the drivesystem of the fluid may include a pressurizing subsystem, which maymanually or automatically be used to apply and/or remove (e.g., via aone-way pressure release valve 2209) positive pressure within the tank2207. This pressure may drive or assist in driving fluid from the tankinto the delivery chambers, where they may be alternatively used to fulland/or deliver material as described above.

In FIG. 17 the storage chamber for holding fluid to be delivered is apressurized. In this example the storage chamber is a bladder 2407 thatcan be filled with fluid; the bladder may expand as fluid is filled,pressurizing it. Thus, the bladder may be an elastic material, such as arubber material or the like. The bladder (also referred to herein as abag, or a collapsible bag) may be connected via multiple valves to afirst delivery chamber 2401 and a second delivery chamber 2401′. Thebladder 2407 may alas include an inlet through with fluid and in someexamples air or neutral material may be inserted the storage chamber(bladder 2407). Thus, in FIG. 17, the storage chamber may act as areservoir to hold fluid and feed the alternating smaller volume deliverychambers (e.g., in some examples, 1 cc or 0.5 cc working syringes).

FIG. 16 illustrates an example of an apparatus as described hereinincluding a force sensitive resistor 2304 as part of the handle 2305.The apparatus is shown partially dissembled, showing the connectionbetween the sensor (e.g., force sensitive resistor 2304), control unit2308 and additional control elements (including switch 2309).

FIGS. 18A-18C illustrate another example of an apparatus, e.g., a devicefor automatic expulsion of a fluid that is configured to be held in auser's hand. In this example, the apparatus may include off-the-shelfcommodity cartridge check valves. The assembly shown in this example issmaller than other examples, and uses injection molded parts. Forexample, FIG. 18A shows an exploded perspective view of the apparatus,showing a front master housing 2503, a right master housing 2512 and aleft master housing 2513. The storage chamber, which may be a housing orbladder as described above, or a larger syringe, as described above, isnot shown, but may be connected, e.g., to an upper threaded pipe 2521within the front housing (as shown in FIG. 18C, in which the fronthousing 2503 has been made transparent). Similarly, the first deliverychamber and a second delivery chamber are not shown, but may be, e.g., 1cc or 3 cc (or 5 cc) syringes that may be attached to threaded pipeconnections 2523, 2525 on the front housing 2503. These pipe connectionsmay be connected to the cartridge check valves 2531 mentioned above,which may be controlled by an electronics assembly 2508 that iselectrically coupled with and controlled by a controller (not shown).The apparatus may also include sensors, additional valves 2518 toconnect to the storage chamber and/or the delivery chamber, etc.

In FIGS. 18A-18C, the apparatus includes a rod 2507 that projects fromthe assembly and acts as aspiration control. This rod may connect to aseparate trigger to allowing one hand operation. As mentioned above, insome examples the storage chamber is configured as a bladder (e.g.,bladder bag) that may be positioned in the handle of the apparatus. Insome examples the storage chamber is a larger chamber (e.g., a 60 ccsyringe).

FIG. 18D shows a front perspective view of an (at least partially)assembled view of the apparatus of FIG. 18A-18C showing the front masterhousing 2503 coupled with the left master housing 2513, and the rightmaster housing 2512 positioned behind the front housing. FIG. 18E showsa back perspective view of the apparatus of FIG. 18D. In FIGS. 18D and18C, couplings (e.g., plastic quick-turn couplings 2533, 2533′ arecoupled to the pipe fittings.

FIG. 19A-19B illustrate the results of the operation of one example of adevice as described herein in injecting fluid material into a tissue. Inthis example, an animal tissue model (e.g., raw chicken breast) wasinjected with a fluid material, such a highly viscous material, using abattery powered injection device as described above. In this experiment,the apparatus was a battery powered device and included a reciprocatingdrive (e.g., a pair of pistons each within a piston chamber) coupled toa manifold as described herein. Both 22-gauge and 25-gauge needles weretested with the apparatus. Water mixed with food coloring was injectedinto uncooked chicken breast 2601. The injection chicken breast wassectioned at the sites of injection performed and examined. The tissuewas sectioned along each vertical path. FIG. 19A shows an example of achicken breast into which the dilute dye solution was injected with a 25Gauge needle using the prototype device, showing effective dying 2605 ofthe tissue to the desired depth. During the injection, resistance to theinjection of the fluid was minimal. FIG. 19B, shows the results of theanimal model (chicken breast 2601′) injected with dye 2615 using a 22Gauge needle on the prototype device. Penetration of injection wasexcellent with both 22 G and 25 G needles.

Overall, the example device functioned very well. The device did notstall with injection with either 22 or 25 gauge needle. The tissue wasinjected multiple times in 2 rows, each row with a different gaugeneedle (e.g., 22 G and 25 G). There was no discernable differencebetween either needles. The syringe did not stall secondary to increasedresistance given the gauge difference.

FIGS. 20A-FIG. 20D show side (FIG. 20A) and side perspective views(FIGS. 20B-20D) of an example of an injection device 2700 for deliveringa fluid (e.g., a viscus fluid). FIG. 20A shows a side view of the device4. The device 4 has a housing 8 (e.g., a first housing), a body region10, a head (anterior) region 12, and a storage chamber (reservoir) 2703.In this example, the upper portion of the housing is transparent, sothat the reservoir, configured as a bag, is visible as are otherfluid-handling components including the manifold 2705 and the driveassembly. The device also includes a trigger control 2709 and a fillport 2707.

FIG. 20B illustrates a side perspective view of the device 2700 showingthe first delivery chamber (first piston chamber) 58. FIG. 20Cillustrates another transparent side perspective view of the device 2700showing the both the first and the second delivery chamber 58 and 78respectively. FIG. 20D illustrates another transparent side perspectiveview of the device 2700 showing the both the piston chambers 58 and 78.

The device 2700 is similar to that shown in FIG. 1A. The body region 10of the device 2700 includes a housing 2701. Within the housing reservoir(configured as a pliable bag 2703), also referred to as a bladder bag,may be filled with a fluid for delivery. The anterior region 12 of thedevice includes a fluid transfer manifold 2705. In general, thereservoir 2703 may be filled with fluid to be injected into patient'sbody. The bag 2703 may be refilled via the fill port 2707, andfluidically connects to the two piston chambers 58 and 78 via themanifold and various valves 140, 142, 144, 146. The valves may be checkvalves (e.g., allowing fluid to pass in one direction but not theopposite direction). The bag 2703 may also be connected through themanifold to a quick turn tube coupling (fill port 2707), which can beopened or closed for filling the bag 2703 with the fluid. The two pistonchamber 58 and 78 are configured to be filled with the fluid from thereservoir 2703 in an alternating fashion, so that as the piston iswithdrawn from the piston chamber, fluid from the reservoir is drawninto the piston chamber. By alternating the movement of the pistons(e.g., pulling one while pushing the other, and vice versa) the pistonchambers may be alternately filled from the reservoir and injected fromthe injection port 2773. In one example, the two piston chambers 58 and78 are configured to work in an alternating pattern to take in the fluidfrom the reservoir 2703 through the fluid transfer manifold 2705 andback out of the manifold and out of the delivery port, using the valves140, 142, 144, and 146 (not shown). As mentioned, these valves may becheck valves. The dispensing of the fluid from the piston chambers 58and 78 may be accomplished when the manifold is in a first configuration(an injection configuration). A selector (control 2788) on the devicemay be used to select between the different modes (e.g., fill, inject,aspirate).

In the example shown in FIG. 20B, the device 2700 is configured tooperate in these three initial modes namely, fill, aspirate, and inject.The device 2700 can be manually switched into any of the above modesusing the selector (e.g., control knob 2711). Before injecting, thereservoir may be filled, e.g., by selecting the fill mode from theselector which may modify the configuration of the manifold (in somecases advancing all or a portion of the manifold, such as a spool withinthe manifold) to fluidically couple the fill port to the reservoir(e.g., bag). Once filled, the device may be primed, for example bysetting the selector (e.g., knob) to inject and running the device for amoment (e.g., while the needle is pointed up) to remove air and move thefluid out through the manifold. In some examples, the device may also oralternatively be operated in an aspiration mode, in which the selectoris adjusted to select the aspiration mode in which the manifold isadjusted so that the fill port is in fluid communication with theinjection port (delivery port) and not with the piston chambers. In somecases when the device is in the fill and/or aspirate mode the driveassembly may be disabled. In the fill mode, the reservoir may be filledby coupling a source of fluid to the fill port, such as from a largersyringe, that can be added to the reservoir. The opening of the fillport may be larger so that material may be injected quickly and easily.When the selector is set to the injection mode, the piston chambers 58and 78 can be filled from the fluid from the reservoir.

In the aspiration mode, negative pressure may be applied to the fillport by, e.g., a small (1 cc, 3 cc, 5 cc, etc.) syringe to draw fluidout of the delivery port. Aspiration can be performed to confirm that aneedle attached to the delivery port is position in a desired locationwithin the structure being injected, and the material aspirated may beviewed through the walls of the syringe or in some cases sampled usingone or more sensors coupled to the fill port.

FIGS. 20B-20D also illustrate a control (e.g., a fluid volume control2799) configured to select between one or more predetermined deliveryvolumes and a continuous mode. When the device 2700 is in the injectmode, it may be placed in the continuous inject mode by setting thefluid volume control 2799 to a continuous injection position. In thecontinuous mode, when the trigger 2709 is pressed, the apparatus willdeliver fluid continuously, until the trigger is released (or until itruns out of fluid, and/or an overpressure event or other error eventoccurs). Alternatively, the fluid volume control may be set to a presetinject mode (e.g., calibrated to inject a predetermined amount, such as1 cc, 2 cc, 3 cc, 4 cc, 5 cc, 10 cc, etc.) when the trigger isactivated. The trigger does not need to be held during delivery of theinjected does. After the injection is complete, additional triggeractuation may cause the delivery of another dose. In the example shownin FIGS. 20B-20D, the fluid volume control is a rotary switch (knob)2799 that may be actuated by the user's finder (e.g., thumb).

Any of these apparatuses may also include circuitry, such as amicrocontroller, for controlling the operation of the device. Thecontroller (e.g., control circuitry) may receive inputs from thecontrols (e.g., the trigger control 2709, the fluid volume control 2799,etc.) and one or more sensors (e.g., pressure sensor, force sensors,etc.). In the example shown in FIGS. 20A-20D, the knob 2799 maycommunicate with the microcontroller (printed circuit board) ordedicated control circuitry, to set the specific mode and to engage thedriver (e.g., motor) to actuate the drive assembly.

In the continuous mode, the fluid may be injected continuously at a ratedetermined by the controller, in some cases by a dedicated circuit. Inany of the preset modes, the fluid may be injected at a fixed rate (andtherefore volume) to specifically inject the predetermined amount of thefluid. The fixed rate and the predetermined amount of fluid may bepre-calibrated (e.g., factory calibrated). In some examples thecontroller may receive input from one or more encoders encoding movementof the drive (e.g., motor) and/or the drive assembly. The controller maydetermine the volume delivered based on the encoder input. For example,when the apparatus is operating in the injection mode, the pistonchambers 58 and 78 have a fixed volume (e.g., 1 cc each, 1.5 cc each, 2cc each, 2.5 cc each, etc.) and may therefore deliver a metered amountof fluid per stroke. Thus the encoder (sensor 100) may determine thenumber of full or partial strokes and therefore the volume. For example,a single physical stroke of fluid may relate to a specific number of anencoder counts. Any appropriate encoder and control circuitry may beused to determine, and limit, the volume delivered per actuation.

An encode may be on the motor, the drive assembly (e.g., drive sprocket,gearing, etc.) and/or the idler. In some examples the encoder is on themotor itself, so that rotational movement of the motor may be detectedproviding a fine control for movement of the drive assembly andtherefore the pistons driving fluid injection. In some examples anencoder may not be used, but instead bang-bang control loop may be usedto control, e.g. continuous ejection of fluid.

The trigger (trigger control 2709) shown in FIGS. 20A-20D includes arubber insert. In some examples, the trigger control may be coupled toforce and/or pressure sensor. For example, the opposite side of therubber insert forming the trigger control may be connect to aforce/pressure sensing resistor. In one example, the resistance of thepressure sensing resistor may be infinite with no pressure and mayreduce to approximately 500 ohms when a pressure is applied. In thisway, the apparatus may determine how much force the user is applying tothe trigger; this force may be used to adjust the rate of movement ofthe driver (e.g., motor) and therefore the drive assembly; this maytherefore set the flow rate and/or pressure of the fluid delivered fromthe delivery port.

As mentioned in FIGS. 20A-20C, the reservoir 2703 is a bag or bladderthat is collapsible. The bag may expand when filled, and may collapse asit empties. This may prevent the delivery of air (bubbles) by theapparatus. In some examples the apparatus may include an air release orremoval portion, such an air-permeable membrane covering an air-ventingregion in fluid communication with the reservoir and/or manifold (orpart of the manifold. As will be described in greater detail below, theapparatus may also include a compression mechanism, such as acompressible foam, to apply pressure against the reservoir so that itcollapses when emptying. The compression mechanism (e.g., collapsiblefoam) may be selected and/or chosen so that the force applied againstthe reservoir is sufficient to collapse it when emptying, but may stillbe sufficiently weak so as to allow it to be filled easily (e.g.,without requiring so much force that it is too difficult to overcome thepressure applied by the compression mechanism. The bag, the manifold,and the piston chambers may therefore work together as the reservoir isfilled so that the collapsed reservoir can expand as fluid fills it andcollapses as the fluid is transferred into the manifold and the pistonchambers. Thus, in some examples, the compression mechanism is anopen-cell foam that may be placed around the bag so that it is under apositive pressure so that the reservoir is collapsed when empty; thismay also aid in driving fluid from the reservoir into the manifold. Inone example, an open cell foam is positioned underneath the reservoir,so that the reservoir is compressed but can spring back with nearlyconstant force as it is filled. The foam always a near-constantpressure. The foam may generally have a very low compression setresistance, so that it returns to the initial, fully expandedconfiguration. Examples of foams may include (but are not limited to)cellular (poly)urethane foams (open cell foams with excellentcompression set resistance), and soft/medium density open cell siliconefoams.

Any of these apparatuses may also include an indicator, such as an LEDindicator, display, etc., to indicate certain safe operating conditions.In some examples the LED may include different color indicators (e.g.,green, blue, red, white, etc.) which may correspond to different alters,such as low/no fluid in the reservoir, pressure too high, power on/off,battery low, etc. In some cases, multiple LEDs, which may be labeled,may be present at different locations on the housing.

In some examples, as discussed above, pressure applied on the trigger2709 in the continuous injection mode may change the injection rate ofthe fluid. For example, higher pressure applied by the user to thetrigger may result in a higher the injection rare and vice versa. Thedevice can be operated at a pressure of 100 psi or higher; in some casespressure may be limited or prevented from exceeding a pressure limitthreshold to prevent harm to tissue when treating a patient. Forexample, in some cases the output pressure of the apparatus from thedelivery port may be limited, e.g., to 600 psi or less, 500 psi or less,400 psi or less, 300 psi or less, 200 psi or less, 150 psi or less, 100psi or less, 90 psi or less, 80 psi or less, 70 psi or less, etc.Pressure may be limited by controlling the speed (or rate) of actuatingthe driver (e.g., motor) and/or the drive assembly that drives thepistons within their respective piston chambers. Pressure may bedetected within the manifold, including with a pressure detectionchamber as will be described in greater detail below in reference toFIGS. 22A-22C.

In some examples the apparatus may be adapted for use withhydrodissection, e.g., application in which high pressure injection maybe used for the treatment of dense connective tissue lesions includingrheumatoid nodules, Dupuytren's contracture, and trigger finger. Inthese cases, the apparatus may be configured to deliver a high pressurebetween about 200 psi and 600 psi specifically. For example, theapparatus may be configured to deliver a higher pressure output whichmay be set by a control on the device. The liquid delivered may besaline or other therapeutic liquid (e.g., drug).

An indicator on or associated with the apparatus may be used to indicateconditions such as “fluid low” or “high pressure” as mentioned. Forexample, a yellow light can indicate that the device low on fluid. or aflashing red color may indicate that the applied pressure (whichtranslates to a the injection rate) exceeds a safe threshold value whichcan lead to too much tissue resistance. This may signal and prompt theuser to remove the device from the tissue and restart.

In operation, the device may first be primed and the trigger pressed. Toprime, the device may be loaded (filled), for example, the reservoir maybe filled by setting the selector to the fill mode (or confirming thatit is already in the fill mode) to place the manifold in the fillingconfiguration, and then attaching a source of fluid to the fill port,such as a 60 cc syringe of fluid material to be injected. With thedevice in the fill mode, the fill port is connected to the reservoir,which may start out collapsed. The fluid may then be added into thereservoir through the fill port, expanding the reservoir. After filling,the selector may be set to the injection mode, and the device may beprimed by aiming it upright (e.g., pointing the delivery port up) whichwill drive any air bubbles in the manifold and/or reservoir towards thedelivery port. In the injection mode, the fluid volume control mayoptionally be set to continuous delivery mode and the trigger may bepressed to operate the device in continuous mode until fluid flowscontinuously out of the device (e.g., in a continuous stream).

In some examples, such as that shown in FIGS. 20A-20D, the upper housing(or upper portion of the housing) is transparent, and/or may include oneor more windows, allowing a view of the reservoir. This may also allow aclear indication of the remaining fluid volume. In some examples thereservoir may also be transparent and/or opaque, to allow the user tosee approximately how much fluid is left. In some examples thecontroller may be configured to detect the fluid amount in reservoir. Agauge may be included to indicate approximately the amount of fluidwithin the device and/or the number of injections (e.g., when using inone or more of the discrete dosing modes) remain.

For example, the apparatus may detect the pressure, e.g., in themanifold, which may be used to indicate the amount of fluid (or at leastthe presence of fluid). For example, if the pressure within the manifoldis negative (or approaches zero for examples in which pressure isapplied against the reservoir) the reservoir may be empty. A negativepulling pressure (e.g., vacuum) can be detected, indicating no morefluid in the bag.

FIGS. 21A-21D illustrate one example of a manifold that may be used. Themanifold, which may also equivalently be referred to herein as amanifold assembly, a plenum, a fluid plenum, or a fluid manifold, mayinclude inputs or connectors to the piston chambers.

For example, in FIGS. 21A-21D, the manifold assembly includes an outerhousing 2102 forming the manifold body that encloses the fluid pathwaysbetween the fill port 2104 and the piston chambers. The fill port may beintegrally formed as part of the manifold assembly or may be separatelyformed and attached thereto. The manifold assembly also connects toand/or is formed integrally with the delivery port 2108. The deliveryport is formed as a Luer lock. Any of the ports described herein may beLuer locks. In this example, the manifold is assembled from a manifoldbody (manifold housing 2102) and a manifold cover or cap 2110. Themanifold cover or cap in this example is attached via a plurality ofscrews.

Generally two or more piston chambers may be used. Each piston chambermay be connected to the manifold, e.g., via a piston manifold connector2112, 2112′ (as shown in FIG. 21C). The manifold may also include aconnector to connect to the reservoir (e.g., reservoir connector 2116).FIG. 21C also shows the spool 2114 that fits into a cylindrical chamberof the manifold. The spool can be displaced relative to the manifoldbody to change the operational mode of the manifold (e.g., betweenfilling, injecting, and/or aspirating). The manifold may also include apressure sensing and/or regulating chamber that includes one or morevents 2118.

FIG. 21D is an exploded view of the example manifold shown in FIG. 21D.In general, the manifold assembly may be relatively compact, andappropriately scaled for use in a hand-held, and lightweight injectiondevice as described and shown herein. In this example the manifold has slength (in the proximal-to-distal axis of the injector apparatus) thatis between about 2 cm and about 10 cm (e.g., 3 cm or less, 4 cm or less,5 cm or less, 6 cm or less, between about 4 cm and 6 cm, etc.), and awidth this is between 4 cm and 12 cm (e.g., about 4 cm or less, about 5cm or less, about 6 cm or less, about 7 cm or less, about 8 cm or less,about 9 cm or less, between about 5-10 cm, between about 6-8 cm, etc.).

In the exploded view of FIG. 21D, the manifold body, the manifoldassembly includes a plurality of valves 2120, 2120′, 2120″, which may becheck valves, that permit fluid flow in just one direction. The checkvalves are in fluid communication with the ports for the piston chambersand may allow fluid to pass from the reservoir and into the pistonchambers (but not from the piston chambers to the reservoir) or from thepiston chambers to the delivery port 2108. In the examples manifoldshown in FIG. 21D four check valves are included within the manifold.The manifold also includes the spool 2122 that may switch theconfiguration of the manifold between filling, injection and aspiration.In general, as used herein a spool is a rod or cylinder that can moveaxially within the manifold. The spool may include one or more sealingrings (e.g., O-rings) around its perimeter. The spool may have one ormore openings through a side of the body into a chamber within thespool. In some examples, multiple chambers may be present. One or bothof the distal and proximal ends of the spool may be open into thechamber within the spool. In this example the spool is an elongatecylinder that includes a plurality of sealing rings dividing the outsideof the spool into discrete regions. The spool also includes a hollowcentral region that is closed at one end, but is open on the oppositeend and may be connected to a ball valve (not visible in FIG. 21D)between the distal end of the spool and the cap of the manifold.

FIG. 21D also include components of a pressure sensor assembly,including a displaceable body 2132 that is held within a pressuresensing chamber of the manifold (not visible in FIG. 21D). where it isheld between the anterior and posterior ends by a pair of biases (e.g.,springs 2134, 2136). One or more sealing rings (e.g., o-rings, gaskets,etc.) 2142, 2144 encircles the displaceable body and divides thepressure sensing chamber into a distal pressure sensing region thatreceives fluid in the manifold (e.g., in the injection mode) and aproximal pressure vent region that is vented 2118 to the atmosphere. Asshown in FIGS. 22B and 22C, showing a side perspective and sidesectioned view of the pressure sensor assembly 2160. The pressure sensorassembly includes a magnet 2140 within the displaceable body of thepressure sensor assembly. The entire pressure sensor assembly 2160 maybe held within the pressure sensing chamber in the manifold. As pressurein the manifold increases or decreases, it may drive the displaceablebody either distally or proximally against the proximal 2136 and distal2134 biases (e.g., springs); movement of the magnet may be detected by amagnetic field sensor assembly 2138 (e.g., including a hall effecttransistor 2139 or other magnetic mounted to or near the baes of themanifold, as will be described in greater detail below, the movement ofthe magnet may therefore be easily and inexpensively read and the sensedpressure within the manifold using to determine that the pressure iswithin a desired range, and/or that there is fluid in the reservoir(e.g., not negative pressure).

For example, as described, the pressure sensor may be configured as apressure-sensing chamber (e.g., bore) that is fluidly connected at oneend to the high pressure side of the manifold. The pressure sensorassembly may include a plunger with an o-ring seal. The end of the boreopposite the high pressure side may be vented to atmosphere (e.g., theproximal end). Two biases, such as two precision springs, may locate theplunger within the bore. As pressure increases in the manifold (e.g.,within the spool), the plunger may move to the vented side of the boreagainst the first spring. If pressure falls below atmosphere, theplunger moves toward the high pressure side. The spring rates may beselected such that the plunger moves a predetermined distance at a givenpressure. For example, the plunger may move 2 mm at a pressure insidethe manifold of 107 psi.

In this example, a magnet may be concentrically housed inside theplunger. For example, an N54 magnet may be axially polarized. The devicemay include a linear hall effect sensor. This sensor may be disposed,e.g., about 1 mm away from the pressure sensing bore which may be about3 mm from the magnet surface. The sensor may be offset from the activehall element such that when the magnet moves, the sensor produces amaximized output signal. This offset may be approximately 3 mm and mayprovide approximately ¼ full scale ratiometric output from 0-107 psi asthe magnet moves about 2 mm. This corresponds to about 300 LSB counts ona 10 bit A/D convertor inside an embedded controller reading the signal.This output is approximately linear and sufficient to allow thecontroller to sense over and under pressure conditions using lower costand robust components.

The fluid manifold assembly may include, e.g., four check valves and oneor more additional valves (e.g., a ball valve), as described inaddition, the body of the manifold assembly may include two chamberswhen assembled and sealed including a low pressure chamber connected tothe reservoir through the spool residing in the chamber. The checkvalves and the high pressure chamber may be connected to the deliveryport (which may be configured as an output needle Luer fitting), throughone or more (e.g., two) output check valves.

In some examples, a ball valve may be positioned at the distal end ofthe spool, so that fluid passing into the spool is selectively operatedto either separate the high-pressure chamber from the output chamber, orto allow fluid to pass from the high pressure to the low pressure(outlet) side. The ball valve may be combined with a spring element toprovide a pressure relief valve functionality if the pressure at theoutput half exceeds some predetermined value. When opening against thespring, fluid returns to the bladder saving the device from damage.

As described above, the apparatus includes three distinct states of thefluid system: injection, filling and aspiration. A selector control(“selector) on the device may include positions corresponding to each ofthese states (“modes”). For example, if the selector control (e.g.,knob) is in the fully counterclockwise position, this may correspond tothe injection position; if the selector control is oriented vertically,this may correspond to the injection position; while if the selectorcontrol is oriented clockwise, this may correspond to the aspirationposition. In the injection state, the reservoir is connected to lowpressure side, a fill/aspirate second Luer may be shut off, and the ballvalve may be held closed. In the fill configuration, the reservoir isfluidly connected to the fill port (which may be a Luer connection) andthe ball valve may be either open or closed. Finally, in the aspirationconfiguration the reservoir connection is closed, the fill port isconnected to the low pressure side (the delivery port), and the ballvalve is open.

As described above, in some variations the apparatus may include aplurality of pinch valves having multiple states, and a cam may berotatable inside the housing with a tube on each side of the housingthat may either shut off one tube while opening the other or open bothtubes. That operation also satisfies the three states described above.The variation shown in FIGS. 20A-20D and 21A-21D does not include tubingor require a pinch valve sub-assembly or barbed fittings.

FIGS. 23A and 23B illustrate cross-sectionals view through an example ofa manifold assembly similar to that shown in FIGS. 20A-20D and 21A-21D.FIG. 23A shows the left side of the manifold assembly, while FIG. 23Bshows the right side of the manifold assembly. These sectional viewsshow the section through the manifold body forming the high pressurechamber in which the spool 2122 resides. The spool including openingsalong its length (four are shown) that pass into the hollow interior2323 of the spool. These openings are each separated from each other bya sealing ring. As the spool is moved axially (e.g.,distally-to-proximally), e.g., by a cam coupled to the selector, theseopenings may reconfigure the manifold to couple the delivery port 2108to the piston chambers (in the injection configuration) through the ballvalve 2325, or to instead couple the delivery port 2108 to theaspiration port 2104.

The manifold body may house four cartridge check valves in four bores.The manifold body may also include the pressure sensing chamber (e.g., alarge space central to those bores and housing a movable pressure sensorassembly 2160). FIGS. 22B and 22C show the pressure sensor assembly, andit is shown in context in the sectional views of FIGS. 23A-23B.

As shown in the example of FIGS. 23A-23B, an 8 mm bore in the manifoldbody includes an opening (proximal opening) into which the spool mayfit. When assembling the manifold, a plastic ball (for ball valve 2325)may be inserted. This bore may have two radial fluid passages; one fluidpath radiates out to a reservoir tube bore where it communicates withthe reservoir, and the second fluid path radiates out to thefill/aspirate bore where is communicates with the fill port 2104.

In this example, a 7.95 mm O.D. spool (e.g., spool valve 2122) isdisposed concentric within the 8 mm bore. This spool may have five ormore o-rings that form three separate fluid chambers that would besealed from each other in the 8 mm bore. As mentioned above, the spoolincludes a central bore that opens to the distal end. Additionally, twopassages connect the central bore to the separated areas between theo-rings. The spool in this example, includes a proximal endincorporating a cage. This cage feature has two vertical internal wallsthat are separated by a defined distance. The cage engages with a camlobe integral to the selector knob shaft. As the selector knob rotatesfrom the 9 o-clock position to the 12 o-clock to the 3 o-clock positionthe cam translates the spool valve assembly through three states. Eachposition may have a detent provided by the knob and the product housing.These three rotation positions may correspond to three lineartranslational positions for the spool valve. Each position selects adistinct fluid connection within the manifold (thereby reconfigurationthe manifold to operate under each of these distinct configurations). Asmentioned, in the inject configuration, the reservoir may be fluidlyconnected to the spools central bore, the passage to the fill/aspirateis completely isolated, and the ball valve is held closed. In thisstate, only the reservoir can supply the input check valves. In the fillconfiguration, the ball valve is open, the reservoir is fluidlyconnected via the spool valve central passage to the fill port (whichmay also be referred to as an aspirate port or a fill/aspirate port). Inthis position, a syringe connected to the fill port (e.g., a Luerfitting on the fill port) can push fluid into the reservoir. In someexamples a shut off valve at the delivery port may be engaged (turnedoff) to prevent flow during bladder filling. In the aspirateconfiguration, the ball valve is open, the reservoir is completelyfluidly isolated, and the fill port is fluidly connected to the spoolvalve central bore. In this position, fluid is allowed to flow from thedelivery port (e.g., through a needle connect to the delivery port),through the ball valve, and into a syringe connected to the fill port.As the surgeon draws the syringe, if the needle is in a blood vessel, atinge of blood may be observed inside the clear needle connection or inthe clear valve body.

Any of the injection apparatuses (devices, systems, etc.) describedherein may be configured as two or more component devices that may becombined prior to use. For example, FIGS. 24A and 24B illustrate anexample of a two-component (two-part) apparatus having an upper,fluid-handling portion 2403 and a lower handle portion 2405 in thisexample, the fluid-handling portion includes the portions that contactand direct fluid in the device. For example the first (upper) housing2411 of the fluid-handling portion may enclose a reservoir, and a firstand second piston chamber, as well as a manifold including the pluralityof check valves (not visible in FIGS. 24A-24B). The fluid-handlingportion also includes a delivery port and a fill port 2404. In addition,the fluid-handling portion also drive assembly (not visible in FIGS.24A-24B) including a transmission that is operatively connected to afirst piston in the first piston chamber and a second piston in thesecond piston chamber so that the drive assembly can reciprocally movethe first and second pistons.

In FIG. 24A, the fluid-handling portion also includes a selector control2488 that includes three positions (inject, fill, and aspirate), shownmarked on the housing.

The fluid-handling portion may be coupled 2450 to the lower, handleportion 2405, as shown in FIG. 24B, showing the fully assembledapparatus 2400. The handle portion may include a second housing 2413that includes a grip region 2415. The handle portion may also includeone or more controls for operating the device, such as a trigger control2409 and a fluid volume control 2429. In this example, the fluid volumecontrol is configured as a dial that may be rotated to select betweenthree fixed-volume settings a continuous flow setting (e.g., 1 cc, 2 cc,3 cc and continuous). The handle portion may enclose or partiallyenclose the driver (e.g., motor) and control circuitry (e.g.,controller). The handle portion (or in some examples, the fluid-handlingportion) may include one or more indicators, such as an indicator light(e.g., LED) 2439 that may indicate, for example, power status (on/off,etc.), error (over-pressure, empty reservoir, etc.), in use/ready, etc.

These two portions, the fluid-handling portion and the handle portionmay be combined together by engaging one or more coupling features 2464on the fluid-handling portion and/or the handle portion. In particular,the driver in the handle portion may engage 2462 with the drive assembly(including the transmission operatively connected to the pistons of thepiston chambers) so that the driver may controllably drive fluid out ofthe injection port of the device. Thus, in some examples the apparatusmay include an upper fluid subassembly (fluid-handling portion) and alower handle portion. This configuration may allow differentsterilization methods for each portion, such as gamma sterilization forthe fluid-handling portion and ethylene oxide gas sterilization for thehandle portion (containing electronics that may be sensitive to somesterilization techniques).

The multiple parts (the fluid-handling portion and the handle portion)of the apparatus may be packaged separately, in sterile packaging, andmay be combined prior to use. In some examples combining the two partsmay activate the device (e.g., turn it “on”) and separating the twoparts may de-activate the device (e.g., turn it “off”) so that aseparate “on” switch is not needed. In some variations a separate“on/off” switch may be included. In some examples the fluid-handlingportion may be disposable, single-patient use and the handle portion maybe reusable with multiple fluid-handling portions (including withmultiple patients). Thus the handle portion may include rechargeablebatteries and may be re-charged during use. In some examples a separate“battery” portion may be swapped into the handle portion, allowingalready-charged batteries to be swapped into the handle (e.g., theapparatus may include three components, rather than just two). Any ofthe apparatuses described herein may be used with a cord that mayprovide power from a wall source (e.g., plug or plug and adapter).

The controller may be configured to operate autonomously or it may beconfigured to communicate, e.g., wireless (via Wi-Fi, Bluetooth, etc.)to a remote server. In some examples the apparatus may transmit statusinformation to a remote server and/or to a handheld device (e.g., phone,etc.). For example, the apparatus may transmit cycle counts, powerstatus, fill status, error status, etc. Alternatively or additionallythe apparatus may include a display on the device (e.g., on the handleportion) for displaying any of this information.

In some examples the fluid-handling portion may be locked (includingreleasably locked) to the handle portion. The lock may be a latch (e.g.,including a hook, snap, clasp, etc.) and may include a release on eitheror both of the fluid-handling portion and/or the handle portion. In someexamples the lock may be on the housing (shell) portion or may becoupled to the housing(s), such as the housing for the fluid-handlingportion and the housing for the handle portion. The lock may preventseparation of the handle portion and the fluid-handling portion unlessand until the lock is disengaged.

As mentioned, the handle portion may include the controller or controlcircuitry. In some examples the apparatus includes firmware that mayincorporate a calibration function (e.g., performed at the factory)where pressure and vacuum are alternately cycled and sensor valuestabulated. The firmware may linearize the data and store permanentcoefficients in EEPROM memory to use for monitoring routines when theapparatus is operating. The calibration process may reduce the need forprecision assembly and tight tolerances.

The pressure-sending subassembly within the apparatus may allow theprocessor to detect when pressure exceeds a safe threshold and it mayalert the user and/or protect the apparatus, e.g., by disabling thedriver and/or venting the device. Additionally, if the device is beingoperated with and empty reservoir, vacuum may be detected and the devicemay issue an alert and/or disable the driver.

FIGS. 25A-25C illustrate side, top and bottom views of one example of aninjector apparatus as described herein, similar to that shown in FIGS.24A-24B. FIG. 25A shows the left side of the device; the controls, suchas the fluid volume control, on the rights side (shown in FIG. 24B) maybe instead located on the left side in some examples. For example,devices may be configured as left-handed or right-handed. The overallform factor may be compact and lightweight, allowing the user to holdand operate the device with one hand, if desired.

FIG. 26 shows a side perspective view of the apparatus of FIGS. 25A-25C,with a portion of the housing(s) made transparent to show thearrangement of components within. In FIG. 26 the handle region enclosesthe power supply (shown as a pair of batteries 2641) as well as powercontrol components, such as a charging port 2643. In this example, thehousing region also encloses control circuitry 2646 that receives inputsfrom the one or more sensors (including pressure/forces sensors coupledto the trigger control 2609 and/or pressure sensors 2645 detectingpressure within the manifold and/or force/pressure sensors for detectingthe force applied by a user to the trigger, and/or encoders for encodingmovement of the driver (e.g., motor 2647). The example shown in FIG. 26also shows a partial view of the drive assembly, including an interface2661 coupling the drive assembly to the plunger (piston 2663) within oneof the piston chambers 2665 that is coupled to the manifold 2675. Theapparatus shown also include a reservoir that has been filled, so thatit displaces a pressure-applying component (shown here as a compressibleballistic foam 2681).

FIGS. 27A-27B illustrate an example of a reservoir assembly including areservoir chamber 2701 and a reservoir inlet/outlet 2703. The reservoirassembly in this example also include a compressible foam 2709 (shown inthe compressed state in the exploded view of FIG. 27B). An additionalattachment or support layer 2711 may also be included. The reservoir inthis example is a polyethylene bag that may be collapsed by theexpansion of the foam when fluid is not present within the reservoir.

FIG. 28A shows an example of a driver (e.g., motor) engaged with a driveassembly of one example of an injector apparatus. In this example, thedrive assembly includes a belt 2865, and a pair of pulleys 2863, 2863′;each piston within the piston chambers may be coupled to the belt, e.g.,using an interface 2866. In the example shown, the drive assembly ismounted to a support 2861. The motor 2647 in this example engages withthe pulleys of the drive assembly and may rotate in either clockwise orcounterclockwise directions to reciprocate the pistons (plungers) of thepiston chambers. The power supply (e.g., batteries 2641) and charger2643 are also shown, as well as the controller 2646, trigger control2609 and pressure/force detector 2831 reading the user-applied force tothe trigger control. Thus this example apparatus includes a rechargingport and also a fixed battery. A typical shelf-life of charge is oneyear.

FIG. 28B shows one example of the first and second piston chambers 2805and pistons (plungers 2807) within each piston chamber. As mentioned,the pistons (plungers) may be coupled to the drive assembly by aninterface; in some examples the interface engages with the ends of theplungers. The distal ends of the piston chambers is shown coupled to amanifold 2811 as described above.

The drive system shown in FIG. 28A may include a home position. In oneexample there may be direction sensing implemented using a hall sensor,a magnet, and encoder on the moving block. When the power is turned on,the moving block may run until the sensor detects a signal. If (e.g., inthe turned-on condition) the home position is not detected, then themotor can run in one direction. Once home position is detected, thesystem may initialize based on the magnetic encoder count; if thetrigger is pressed, the direction the drive systems turns is known fromthe detected home position.

Any of the apparatuses described herein may include hardware, softwareand/or firmware that may track the operation of the device, includingthe number of cycles performed. The controller/control circuitry mayinclude one or more memories or registers that may record the number ofcycles. In some examples if the number of cycles exceeds a cycle limitthreshold, the apparatus may shut down (a warning may be issued a fixednumber of cycles before shut-down). For example, after 400 cycles, after425 cycles, after 450 cycles, after 500 cycles, after 550 cycles, after600 cycles, etc.

In some examples the apparatus may track the number of cycles fromfilling of the reservoir. As mentioned, these cycles may be displayed(e.g., in a display on the device or in communication with the device,including in wireless communication with the device).

Any of the apparatuses described herein may include valves at one ormore of the ports (e.g., the fill port, the deliver port). For example,the fill port may include a Luer lock with a valve that may preventbackflow when removing the filling source from the fill port. Forexample, the fill port and/or the delivery port may include a manuallyoperated valve (switch) to open/close the port.

Thus, the injection apparatuses described herein may be battery/motorpowered apparatuses to deliver fluid into tissues of varying resistancein a controlled manner while relieving the physiological stress impartedon the surgeon/operator. Any of the apparatuses described herein may beconfigured for use with an external device, such as a navigation unit,robot and/or artificial intelligence system. For example, theseapparatuses may be fitted with external arrays and registration/checkpoints and internal inclinometer/microsensors that may record fluidvelocity/volume/resistance to help identify anatomic location of theinjection, volume/resistance of the fluid injected. Any of theseapparatuses may emit data (e.g., by radiofrequency, Wi-Fi_33, etc.). Theapparatus may record/provide feedback on the volume, velocity,resistance during injection, and anatomical location of the materialdelivered. Any of these apparatuses may include an inclinometer todescribe the orientation of the device during usage. In some examplesthe apparatus may be fitted with arrays/registration points to interactwith robotic and navigation devices to allow these devices to interpretthe dimension/location/orientation of the device at the time of theinjection. This may allow for an understanding, recording and/oranalysis of the anatomical location where the device was delivering itsintended product. The use of position/orientation and/or appliedpressure/force may be implemented with either a single-use disposableapparatus and/or with a modular (e.g., partially disposable) apparatus.

For example, injection volume, velocity and/or resistance data from theapparatus can be transmitted in real-time wirelessly (e.g., viaradiofrequency, Bluetooth, Wi-Fi, etc.) and/or uploaded at a later timeto a remote processor that may analyze the data. For example, the remoteprocessor may receive the gauge of needle used, the type of materialinjected, location/volume of injected material, time(s) during theprocedure that materials were injected, composition of injectedmaterial, etc. The remote processor may analyze this data in conjunctionwith the anatomical location of injection, velocity, resistance and/orvolume of injection and pre/post-operative functional outcomes.

For example, any of the apparatuses descried herein may work with adatabase of injection information that may be generic (e.g., notspecific to a particular patient). Thus, these apparatuses may beconfigured to contribute to a database of injection information asdescribed above. This database, which may be maintained in one or moreremote locations, may be analyzed and used to optimize treatments forpatients, and/or to optimize the functioning of the injectionapparatuses. For example, a system including a database of injectioninformation may identify specific locations, volumes and/or substratesthat may be indicated for use in order to improve pre-operative throughpost-operative outcomes for patients. Thus, these databases may receiveinformation regarding pain, immediate post-op function, and consumptionof pain medication post-operatively; this information may be correlatedwith the functional aspects of the apparatuses delivering the treatment.A machine learning agent may interpret this information and may indicateone or more: locations to deliver treatment, delivery rates, deliveryvolumes, etc. These systems and methods may also or alternativelyidentify the efficacy of substrates injected, as it pertains to thespecific composition, volume and/or location of the injection; forexample, these systems may determine if a local anesthetic, e.g.,Exparel, is an effective pain medication for a particular patient orclass of patients.

Thus, any of the apparatuses described herein may be configured toprovide operational information to a remote database for processing; theoperational information may be correlated with treatment information(that may be patient specific or unaffiliated with a particularpatient). For example, the apparatus may be uniquely identified via acode specific to the apparatus or to a particular operation of thedevice. A particular operational instance (e.g., use) of the device mayinclude information (which may be transmitted to the remote database bythe user or a party working with the user) that may include pre- andpost-operative functional data for the patient, a location of theprocedure being performed with the apparatus (e.g., hospital/hospitaloutpatient department/ambulatory surgery center), pre- andpost-operative consumption of NSAIDS, Tylenol, narcotic, etc.medications by the patient, etc. The apparatus may also transmit withthe same identifier, intra-operative data obtained through the use ofthis apparatus, as described above. The remote processor may assess theefficacy of the method and/or the type of substrate injected and/or thelocation of the injection/volume of substrate injected.

Thus, a system (which may include hardware/software and/or firmware) mayanalyze information such as that described above, including all or someof: patient profile (age, sex, BMI, bone density), pre/post-operativefunctional/psychological/etc. scores, pre-operative x-ray evaluation,pre-operative physical exam, post-operative x-ray, post-operativephysical exam, medication utilized pre- and post-operatively, locationwhere surgery was performed procedure (hospital/hospital outpatientdepartment/ambulatory surgery center), (orthopedic, or other) implantused, type of substrate injected (anesthetic, filler, etc.), and/oranatomical location/volume/speed/resistance of injection. This system,when used in conjunction with an orthopedic robot and/or navigationsystem, may utilize identify treatment parameters for treating patients,including treating patient's to restore anatomical alignment/range ofmotion/balance of a knee replacement, location of where a procedure isperformed (hospital vs ASC), type of anesthetic used (spinal vsgeneral+/−peripheral nerve block), location/volume injected/type ofanesthetic injected, peri-operative medication utilized, which type oforthopedic implant/design to use (e.g., cruciate retaining vs posteriorstabilized), etc. These systems may also provide expected functionaloutcomes specific to a particular patient's profile. For example, thesesystems may also or alternatively provide treatment parameters foroperation of the injection apparatus, such as injection location(s),and/or injection volumes, rate of injection, etc.

As mentioned, any of these apparatuses described herein may beconfigured to operate with a system including a database of injectiontreatment parameters. For example, any of these apparatuses may includea communications sub-system, such as a wireless communication circuitry;the controller of the apparatus may use the wireless circuitry tocommunicate with a remote database. The controller may also includetiming information (e.g., clock, calendar, etc. information). Any of theinjection apparatuses described herein may include one or more trackingcomponents. The tracking data may be stored, modified (e.g., filtered,compressed, etc.) and/or transmitted, etc. to a remote processor asdescribed. FIG. 29 illustrates one example of tracking components one ormore of which may be included in any of the apparatuses describedherein.

In FIG. 29, a two-component apparatus (similar to that shown in FIG.24A-24B) is show, however, the tracking components may be included inany of these apparatuses. In FIG. 29, the apparatus may include atracking array 2903, which may be, e.g., an infrared reflective material2905 (e.g., sphere, disk, etc.), which may be on the apparatus. Atracking system may be positioned near the patient to track movementand/or orientation of the injection apparatus during a procedure,including tracking the one or more (preferably three or more) IRtracking markers (e.g., IR reflective materials). In some examples theapparatus (e.g., either or both the fluid-handling portion and/or thehandle portion) may include one or more registration checkpoints. InFIG. 29, three registration checkpoints 2907, 2907′, 2907″ are shown,located on the distal end (near the delivery port), the proximal end (onthe fluid-handling portion), and at the base of the handle portion.These registration checkpoints may be tracked using, e.g., an externaltracking apparatus. The tracking information may be correlated (andstored, transmitted, etc.) with operational information from theinjection apparatus (including injection flow rates, amounts, etc.), aswell as with additional patient-specific data (procedures, outcomes,etc.).

Any of the apparatuses described herein may be further adapted for usewith a robotic system. For example, the injection apparatus may beadapted for use with a robotic arm that may position and deliver aninjection from the apparatus. Thus, the handle portion may be adaptedfor interacting with a robotic arm; the robotic arm may engage with thehandle portion, including the trigger, and may position and actuate theapparatus. The tracking markers on the apparatus (e.g., FIG. 29) mayassist the navigation and/or control system for the robotic apparatus.

Examples

Also described herein are apparatuses having alternative configurationsfor the fluid delivery and aspiration components of the apparatusesdescribed herein. For example, FIG. 30 illustrate another example of anapparatus as described herein. In this example, the core components ofthe injection apparatus are show, showing the drive assembly, tubing andmultiple check valves; in this example the apparatus does not include adedicated manifold as described above. The apparatus shown in FIG. 30include an aspiration port 3005, a delivery port 3001, a shuttle dualcheck valve 3007, top fill port 3009, trigger control 3015, pistonchamber(s) 3019, and cylindrical reservoir 3011. FIGS. 30B and 30C showside perspective and bottom views, respectively, of the same apparatus.

This example of an injection apparatus may have a plunger that can beactivated by the finger of the user while holding the handle of thedevice. The retraction of the shaft with the trigger and plunger wouldcreate a vacuum at the tip of the device pulling fluid from the needleback into the clear tube at the end of the device. A blush would showinforming the user that the tip of the needle is in the vascular system.

The apparatus can also be configured to block fluid flow during thefilling operation of the device. For example, the user can hold thedevice, retract the trigger blocking the flow of fluid out of the needleport and forcing the liquid to fill the reservoir. The trigger couldthen be released allowing the user to prime the system using the fillport.

Any of these apparatuses, including the apparatus shown in FIG. 30A, maybe configured to include a plurality of shuttles within the fluid pathto act as a dual check valve for directing fluid from the reservoir tothe smaller piston chambers (e.g., syringes) and out the piston chambersto the needle as the plungers of the small syringes are drawn back andforth. The shuttles may have a hollow center portion from the back endto a through hole in the front section. The outer surface of the shuttleand the inner surface may be configured such that fluid cannot passaround the shuttle. This can be accomplished with matching diameters orwith a mechanical bushing. The shuttle can be in two states at theextreme of its travel; one state when the shuttle is drawn back towardthe small syringe in line with the shuttle. This may occur when theplunger on that shuttle is being pulled out expanding the volume of thesyringe and pulling a vacuum to draw fluid into the syringe. The vacuumdraws the shuttle back toward the syringe, closing off the fluid path tothe needle exit port and opening the path from the reservoir to thesmaller syringe. When the plunger switches direction and begins to expelfluid from the syringe, the shuttle is pushed all the way forward. Theouter diameter of the back portion of the shuttle blocks flow into thereservoir and the path is through the body of the shuttle out the exithole in the front of the shuttle into the exit path of the needle.Because the two syringes are set to be moving always in oppositedirections there will always be fluid pumping from the reservoir into asmall syringe and fluid being expelled from a small syringe out of theneedle.

For example, FIG. 31 shows an enlarged view of the shuttle 3021 fromFIGS. 30A-30C. In FIG. 31, the shuttle includes a thru hole and a frontsection port.

FIGS. 32A and 32B show schematic illustrations of two different fluidsystems including an aspirate valve. The apparatuses described hereinmay be configured according to either of these schematics. In FIG. 32A,the fluid-handing circuit includes a pair of piston chambers 3211, areservoir 3205, a fill port 3207, a delivery port 3209, and five checkvalves 3213. FIG. 32B shows an alternative arrangement, including anaspiration port 3219. These apparatuses can be filled from the top witha port that can accept a large syringe, for example. The access line mayhave an inline check valve to allow fluid into the system withoutallowing back flow.

In any of these apparatuses, the reservoir can be a larger syringe withthe plunger extension removed. This may decrease the length requirementof a full syringe, but allows the advantages of a piston configurationsuch as a clear tube to identify air in the system, clear visualizationof the amount of fluid remaining in the reservoir, and familiarity ofthe device by the user. Markings on the cylinder can indicate theaccrual of fluid volume during filling and the expelling of fluid duringinjection. This may also provide feedback to the user. The user can seeif the plunger is moving as they dispense fluid indicating properoperation and warning that fluid is running low.

FIGS. 33, 34 and 35 illustrate methods for preparing for use, using andcompleting use of an injection apparatus as described herein. Thesemethods, and/or any or all of the component steps of these methods, maybe combined for an overall method of use. These methods may be used withany of the apparatuses described herein. For example, FIG. 33illustrates a method of preparing an injection apparatus for use. Forinjection apparatuses that include multiple portions that may be keptseparate before use (such as shown and described in FIG. 24A-24B,above), the apparatus may first be assembled 3301. For example, an upperhalf (e.g., a disposable portion), such as a fluid-handling portion anda lower half (e.g., reusable) portion such as a handle portion, may bekept separately in sterile conditions and may be assembled by attachingtogether. Combining upper half and lower half may power on theapparatus. In some examples a light, e.g., an LED, may illuminate toindicate the device is assembled, powered and ready for use. In someexamples the apparatus may be initially set so that it is in a fillmode; alternatively, the device may be set into the fill mode by settinga selector (e.g., knob) to a “fill” position 3303. The device may thenbe filled. In some cases, the user may manually close the delivery port(e.g., by attaching a cap and/or by switching a valve on the deliveryport to closed 3305. Alternatively in some examples the apparatus mayautomatically close off the delivery port.

Prior to filling the fluid to be injected may be prepared. For example,if a drug (e.g., Exparel, Bupivacaine, Marcaine, etc.) is to beinjected, it may be premixed to the appropriate concentration. The fluidmay then be loaded into the reservoir of the apparatus 3307. In someexamples, the fluid may be added by a syringe or other filling devicethat may couple to the fill port on the apparatus. For example, a 60 ccsyringe full of fluid (e.g., liquid drug) may be attached to the Luerconnection of the fill port and the piston of the 60 cc syringe pushedin to deliver the liquid into the reservoir, which may expand as itreceives the liquid (preventing air bubbles). Once filling is complete,in some examples the apparatus may be switched to an injection oraspiration mode, which may close the path between the fill port and thereservoir (preventing back flow from the reservoir. As mentioned above,in some examples the path between the reservoir and the fill port mayinclude a check valve preventing back flow; alternatively a manual valve(switch) may be included to shut off the connection between the fillport and the reservoir.

A needle of any appropriate size may then be attached to the injectionport (e.g., via a Luer lock) 3309. The apparatus may then be primed3311, to remove air within the device. For example, the apparatus may beprimed by aiming the apparatus up and, with the device in the continuousflow mode, the trigger depressed until a continuous stream of fluid isejected.

Once loaded and optimally primed, the apparatus may be used to injectfluid. For example, as shown in FIG. 34, the device may be placed in theinjection mode (or configured that it is in the injection mode) 3401.Further, the type of injection, such as continuous or preset volume, maybe selected, e.g., by the user adjusting a fluid volume control toselect from one or more predefined volumes (e.g., 1 cc, 2 cc, 3 cc, 4cc, 5 cc, 6 cc, 7 cc, 8 cc, 9 cc, 10 cc, etc.) and/or a continuousinjection mode (“freestyle”) 3403.

The needle may then be inserted into the region to be injected (e.g., insome examples, a patient tissue) 3405. In some cases the user may wishto confirm that, e.g., when injecting into a body, that the region ofthe body in which the needle is inserted is not in a blood vessel (orother region) by aspirating from the body out of the device. Theselector of the apparatus may be set to an aspirate mode so that theneedle (through the delivery port) is fluidly connected to the fill port(or in some examples, a separate aspiration port); a syringe may beattached to the fill/aspiration port and may be used to withdraw fluidfrom the body 3407. Once confirmed, the selector may be set to theinject mode and the user may apply pressure to the trigger control ofthe device to expel fluid from the apparatus 3409. During operation, theapparatus may confirm that the pressure within the apparatus (e.g.,within the manifold in variations including a manifold) is within a saferange. Negative pressure within the apparatus may indicate that thereservoir is empty. If the pressure exceeds a pressure threshold, theapparatus may enter a fault mode, e.g., disabling the drive or drivesubsystem.

When a predetermined volume injection has been selected, triggering thedevice may deliver the predetermined volume 3411. Alternatively acontinuous mode may allow the user to inject fluid continuously. In someexamples, the user may adjust the rate of injection (of the fluid beinginjected) by increase or decreasing the pressure on trigger control. Theuser may repeatedly remove and re-insert the needle into different sitesto be injected 3413. The apparatus may be re-filled, either before orafter the apparatus has indicated that the reservoir is empty, bycoupling a source of filling material (e.g., drug) to the fill port andplacing the apparatus in the fill configuration (e.g., by changing theselector setting) 3415. The steps for filing and/or priming described inFIG. 33 may be repeated.

Once the injections are complete, the apparatus may be prepared fordisposal and/or reuse or partial re-use. For example, the needle may beremoved 3501. The device may be de-powered 3503 (either before or afterremoving the needle). In examples in which the apparatus includesmultiple portions (such as a fluid-handling portion and a handleportion), the handle portion may be separated from the fluid-handlingportion 3505 and, if desired, reused, while the fluid-handling portionmay be disposed of (as medical waste). If the handle portion is to bereused, it may be recharged, or the batteries replaced. If the handleportion is to be disposed of, the components (e.g. battery, circuitry,motor, etc.) may be removed and recycled.

Although various illustrative examples are described above, any of anumber of changes may be made to various examples without departing fromthe scope of the invention as described by the claims. For example, theorder in which various described method steps are performed may often bechanged in alternative examples, and in other alternative examples oneor more method steps may be skipped altogether. Optional features ofvarious device and system examples may be included in some examples andnot in others. Therefore, the foregoing description is providedprimarily for exemplary purposes and should not be interpreted to limitthe scope of the invention as it is set forth in the claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific examples in which thesubject matter may be practiced. As mentioned, other examples may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such examples of the inventive subject matter may bereferred to herein individually or collectively by the term “invention”merely for convenience and without intending to voluntarily limit thescope of this application to any single invention or inventive concept,if more than one is, in fact, disclosed. Thus, although specificexamples have been illustrated and described herein, any arrangementcalculated to achieve the same purpose may be substituted for thespecific examples shown. This disclosure is intended to cover any andall adaptations or examples of various examples. Combinations of theabove examples, and other examples not specifically described herein,will be apparent to those of skill in the art upon reviewing the abovedescription.

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one example, the features and elements so described orshown can apply to other examples. It will also be appreciated by thoseof skill in the art that references to a structure or feature that isdisposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularexamples only and is not intended to be limiting of the invention. Forexample, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements (including steps), these features/elementsshould not be limited by these terms, unless the context indicatesotherwise. These terms may be used to distinguish one feature/elementfrom another feature/element. Thus, a first feature/element discussedbelow could be termed a second feature/element, and similarly, a secondfeature/element discussed below could be termed a first feature/elementwithout departing from the teachings of the present invention.

Throughout this specification and the claims which follow, unless thecontext requires otherwise, the word “comprise”, and examples such as“comprises” and “comprising” means various components can be co-jointlyemployed in the methods and articles (e.g., compositions and apparatusesincluding device and methods). For example, the term “comprising” willbe understood to imply the inclusion of any stated elements or steps butnot the exclusion of any other elements or steps.

In general, any of the apparatuses and methods described herein shouldbe understood to be inclusive, but all or a sub-set of the componentsand/or steps may alternatively be exclusive and may be expressed as“consisting of” or alternatively “consisting essentially of” the variouscomponents, steps, sub-components or sub-steps.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical valuesgiven herein should also be understood to include about or approximatelythat value, unless the context indicates otherwise. For example, if thevalue “10” is disclosed, then “about 10” is also disclosed. Anynumerical range recited herein is intended to include all sub-rangessubsumed therein. It is also understood that when a value is disclosedthat “less than or equal to” the value, “greater than or equal to thevalue” and possible ranges between values are also disclosed, asappropriately understood by the skilled artisan. For example, if thevalue “X” is disclosed the “less than or equal to X” as well as “greaterthan or equal to X” (e.g., where X is a numerical value) is alsodisclosed. It is also understood that the throughout the application,data is provided in a number of different formats, and that this data,represents endpoints and starting points, and ranges for any combinationof the data points. For example, if a particular data point “10” and aparticular data point “15” are disclosed, it is understood that greaterthan, greater than or equal to, less than, less than or equal to, andequal to 10 and 15 are considered disclosed as well as between 10 and15. It is also understood that each unit between two particular unitsare also disclosed. For example, if 10 and 15 are disclosed, then 11,12, 13, and 14 are also disclosed.

What is claimed is:
 1. A system for injecting a fluid, the systemcomprising: a fluid-handling portion comprising: a first piston chamberconfigured to fluidically connect to a reservoir through a manifold; asecond piston chamber configured to fluidically connect to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; and a drive assemblycomprising a transmission operatively connected to a first piston in thefirst piston chamber and a second piston in the second piston chamber,wherein the drive assembly reciprocally moves the first piston and thesecond piston to drive fluid in a continuous flow out of the deliveryport by alternately driving fluid from the second piston chamber and thefirst piston chamber out of the delivery port while alternatelytransferring fluid from the reservoir into the first piston chamber andthe second piston chamber; and a handle portion comprising: a motorconfigured to couple to the drive assembly; a trigger control configuredto activate the motor; and a grip region configured to be held in auser's hand, wherein the handle portion and the fluid-handling portionare configured to releasably couple so that the motor engages with thedrive assembly to reciprocate the first piston and the second piston. 2.The system of claim 1, further comprising a latch configured toreleasably secure the fluid-handling portion to the handle portion. 3.The system of claim 1, further comprising a magnet within the manifoldof the fluid-handling portion configured to move relative to an internalfluid pressure within the manifold, wherein the handle portion comprisesa magnetic sensor configured to detect a position or a change inposition of the magnet.
 4. The system of claim 1, further comprising aselector coupled to the manifold and configured to select between aninjection configuration of the manifold, a filling configuration of themanifold and an aspiration configuration of the manifold.
 5. The systemof claim 4, wherein in the injection configuration the delivery port isin fluid communication with the first piston chamber and the secondpiston chamber, wherein in the filling configuration the delivery portis closed and the reservoir is in fluid communication with a fill port,and wherein in the aspiration configuration the delivery port is influid communication with the fill port through the manifold.
 6. Thesystem of claim 4, wherein the selector is within the fluid-handlingportion.
 7. The system of claim 1, further comprising a fluid volumecontrol on the handle portion configured to select between one or morepredetermined delivery volumes or a continuous mode, wherein the systemdelivers a volume of fluid based on a setting of the fluid volumecontrol when the user actuates the trigger control.
 8. The system ofclaim 1, further wherein the handle portion comprises a fluid volumecontrol selectable by the user and configured to select between one ormore predetermined delivery volumes and a continuous mode, and acontroller, wherein the controller controls the motor to deliver avolume of fluid based on a setting of the fluid volume control when theuser actuates the trigger control.
 9. The system of claim 1, furthercomprising an indicator indicating when the reservoir is empty.
 10. Thesystem of claim 1, further comprising an overpressure relief value inthe manifold.
 11. The system of claim 1, further comprising an indicatorindicating when a pressure within the manifold exceeds a thresholdvalue.
 12. The system of claim 1, wherein the manifold is configured sothat a first check valve and a second check valve are fluidly coupled toan input to the first piston chamber so that when the manifold is in aninjection configuration fluid is passed from the reservoir into thefirst piston chamber as the first piston is withdrawn in the firstpiston chamber and fluid is passed from the first piston chamber out ofthe delivery port when the first piston is advanced in the first pistonchamber, wherein the manifold is further configured so that a thirdcheck valve and a fourth check valve are fluidly coupled to an input tothe second piston chamber so that in when the manifold is in theinjection configuration fluid is passed from the reservoir into thesecond piston chamber as the second piston is withdrawn in the secondpiston chamber and fluid is passed from the second piston chamber out ofthe delivery port when the second piston is advanced in the secondpiston chamber.
 13. A system for injecting a fluid, the systemcomprising: a fluid-handling portion comprising: a reservoir; a firstpiston chamber fluidically connected to the reservoir through amanifold; a second piston chamber fluidically connected to the reservoirthrough the manifold; a plurality of check valves in the manifold; adelivery port fluidically connected to the first piston chamber and thesecond piston chamber through the manifold; a drive assembly comprisinga transmission operatively connected to a first piston in the firstpiston chamber and a second piston in the second piston chamber, whereinthe drive assembly reciprocally moves the first piston and the secondpiston to drive fluid in a continuous flow out of the delivery port byalternately driving fluid from the second piston chamber and the firstpiston chamber out of the delivery port while alternately transferringfluid from the reservoir into the first piston chamber and the secondpiston chamber; and a selector configured to select between an injectionconfiguration of the manifold, a filling configuration of the manifoldand an aspiration configuration of the manifold; and a handle portionconfigured to be held in a user's hand, the handle portion comprising: amotor configured to couple to the drive assembly; and a trigger controlconfigured to activate the motor; wherein the handle portion and thefluid-handling portion are configured to releasably couple so that themotor engages with the drive assembly to reciprocate the first pistonand the second piston.
 14. A method, the method comprising: assembling afluid-handling portion of an injection system with a handle portion ofthe injection system by coupling the fluid-handling portion to thehandle portion so that a motor in the handle portion engages a driveassembly in the fluid-handling portion; filling a reservoir within thefluid-handling portion with a fluid while a selector on thefluid-handling portion is set to a fill position so that a manifoldwithin the fluid-handling portion is in a fill configuration with thereservoir in fluid communication with a fill port on the fluid-handlingportion through the manifold; setting the selector on the fluid-handlingportion to an injection position so that the manifold is in an injectionconfiguration in which a delivery port of the fluid-handling portion isin fluid communication with a first piston chamber, a second pistonchamber and the reservoir through a plurality of check valves; andejecting fluid from the delivery port when a trigger control on thehandle portion is activated by activating the motor so that the driveassembly reciprocally drives a first piston in the first piston chamberand a second piston in the second piston chamber to alternately transferfluid from the reservoir and into the first piston chamber and thesecond piston chamber, and to alternately drive fluid from the secondpiston chamber and the first piston chamber out of the delivery port ina continuous flow.
 15. The method of claim 14, wherein assembling thefluid-handling portion turns on power to the injection system.
 16. Themethod of claim 14, further comprising attaching an injection needle tothe delivery port.
 17. The method of claim 14, further comprisingsetting the selector to a fill position prior to filling the reservoir.18. The method of claim 14, further comprising priming the injectionsystem.
 19. The method of claim 14, further comprising closing thedelivery port before filling the reservoir.
 20. The method of claim 14,further comprising setting a fluid volume control to a pre-set volumemode or to a continuous delivery mode prior to ejecting fluid from thedelivery port.
 21. The method of claim 14, wherein ejecting fluid fromthe delivery port comprises ejecting fluid to a predefined volume when afluid volume control is set to a predefined volume mode.
 22. The methodof claim 21, wherein ejecting fluid to the predefined volume comprisesencoding movement of the drive assembly and comparing the encodedmovement to a predefined value.
 23. The method of claim 14, whereinejecting fluid from the delivery port comprises adjusting a rate ofmovement of the drive assembly based on force applied to the triggercontrol.
 24. The method of claim 14, wherein ejecting fluid from thedelivery port comprises continuously ejecting fluid from the deliveryport while the trigger control is activated by a user.
 25. The method ofclaim 14, wherein ejecting fluid from the delivery port comprisesreciprocating the motor so that the motor is driven alternatelyclockwise and counterclockwise.
 26. The method of claim 14, furthercomprising setting the selector on the fluid-handling portion to anaspiration position so that the manifold is in an aspirationconfiguration in which the delivery port is in fluid communication withthe fill port and the reservoir, the first piston chamber and the secondpiston chamber are not in fluid communication with the delivery port.27. The method of claim 26, further comprising aspirating through theinjection system by applying suction to the fill port.